Dispositifs Médicaux Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Showing 24 of 2,119 results
Medical Device
FDA Devices
FDA DevicesMedica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Medica Corporation
FDA DevicesClass II
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Feb 25, 2026Medica Corporation
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesDa Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Intuitive Surgical, Inc.
FDA DevicesClass II
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Feb 25, 2026Intuitive Surgical, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Feb 25, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) MINOR EYE PACK, Model Number: DYNJ17219C; 12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 13) EYE PACK, Model Number: DYNJ41207C; 14) OPHTHALMIC PACK, Model Number: DYNJ42043I; 15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 17) EYE PLASTIC PACK, Model Number: DYNJ47859B; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) CATARACT PACK, Model Number: DYNJ53019A; 20) CATARACT PACK, Model Number: DYNJ54869A; 21) VITRECTOMY PACK, Model Number: DYNJ55280B; 22) NDNW-EYE PACK, Model Number: DYNJ61779C; 23) EYE PK, Model Number: DYNJ62306; 24) VITRECTOMY, Model Number: DYNJ64220; 25) OSC BREAST PACK, Model Number: DYNJ65808C; 26) MILLS CATARACT PACK, Model Number: DYNJ67973A; 27) EYE PACK, Model Number: DYNJ68367B; 28) CATARACT PACK, Model Number: DYNJ68875D; 29) CATARACT PACK, Model Number: DYNJ68875F; 30) CATARACT PACK, Model Number: DYNJ68875G; 31) OPHTHO PLASTIC, Model Number: DYNJ902256C; 32) RETINAL, Model Number: DYNJ907495; 33) CATARACT, Model Number: DYNJ909924; 34) COMBO EYE, Model Number: DYNJ909925; 35) VITRECTOMY, Model Number: DYNJ909929
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) MINOR EYE PACK, Model Number: DYNJ17219C; 12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 13) EYE PACK, Model Number: DYNJ41207C; 14) OPHTHALMIC PACK, Model Number: DYNJ42043I; 15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 17) EYE PLASTIC PACK, Model Number: DYNJ47859B; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) CATARACT PACK, Model Number: DYNJ53019A; 20) CATARACT PACK, Model Number: DYNJ54869A; 21) VITRECTOMY PACK, Model Number: DYNJ55280B; 22) NDNW-EYE PACK, Model Number: DYNJ61779C; 23) EYE PK, Model Number: DYNJ62306; 24) VITRECTOMY, Model Number: DYNJ64220; 25) OSC BREAST PACK, Model Number: DYNJ65808C; 26) MILLS CATARACT PACK, Model Number: DYNJ67973A; 27) EYE PACK, Model Number: DYNJ68367B; 28) CATARACT PACK, Model Number: DYNJ68875D; 29) CATARACT PACK, Model Number: DYNJ68875F; 30) CATARACT PACK, Model Number: DYNJ68875G; 31) OPHTHO PLASTIC, Model Number: DYNJ902256C; 32) RETINAL, Model Number: DYNJ907495; 33) CATARACT, Model Number: DYNJ909924; 34) COMBO EYE, Model Number: DYNJ909925; 35) VITRECTOMY, Model Number: DYNJ909929
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Feb 25, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesTeslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Wilson-Cook Medical Inc.
FDA DevicesClass II
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Feb 25, 2026Wilson-Cook Medical Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Feb 25, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Feb 25, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesMOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Stryker Corporation
FDA DevicesClass II
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Feb 25, 2026Stryker Corporation
Medical DeviceFDA Devices
FDA DevicesPrivate Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Feb 25, 2026Integra LifeSciences Corp. (NeuroSciences)
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Medline Industries, LP
FDA DevicesClass II
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Feb 25, 2026Medline Industries, LP
Medical Device
UK
UKField Safety Notices: 16-20 February 2026
MHRA
uk-mhraMedical Device ...
Field Safety Notices: 16-20 February 2026
List of Field Safety Notices: 16-20 February 2026...
Feb 24, 2026MHRA
Medical DeviceFDA Devices
FDA DevicesLaerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
Laerdal Medical Corporation
FDA DevicesClass II
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
Feb 18, 2026Laerdal Medical Corporation
Medical DeviceFDA Devices
FDA DevicesMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Medline Industries, LP
FDA DevicesClass II
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Feb 18, 2026Medline Industries, LP