Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Showing 24 of 2,022 results
Medical Device
UK
UKCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
MHRA
uk-mhraMedical Device ...
Cobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of rev...
Aug 26, 2026MHRA
Medical DeviceUK
UKField Safety Notices: 17 to 21 August 2026
MHRA
uk-mhraMedical Device ...
Field Safety Notices: 17 to 21 August 2026
List of Field Safety Notices from 17 to 21 August 2026....
Aug 24, 2026MHRA
Medical DeviceUK
UKNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
MHRA
uk-mhraMedical Device ...
NGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
The NGPod handheld device and NGPod sensor, used to test pH to aid the placement of nasogastric tubes, is being withdrawn from the UK market. The manufacturer has ceased trading in the UK. Users shoul...
Aug 24, 2026MHRA
Medical Device
FDA Devices
FDA DevicesMedline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Medline Industries, LP
FDA DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Aug 19, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesCardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
Cardinal Health 200, LLC
FDA DevicesClass II
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Aug 19, 2026Cardinal Health 200, LLC
Medical DeviceFDA Devices
FDA Devicesnavify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.
Ventana Medical Systems, Inc.
FDA DevicesClass II
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Aug 19, 2026Ventana Medical Systems, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Industries, LP
FDA DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Aug 19, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesCardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
Cardinal Health 200, LLC
FDA DevicesClass II
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Aug 19, 2026Cardinal Health 200, LLC
Medical DeviceFDA Devices
FDA DevicesMedline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Industries, LP
FDA DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Aug 19, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesGLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Terumo Medical Corporation
FDA DevicesClass II
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Aug 19, 2026Terumo Medical Corporation
Medical DeviceFDA Devices
FDA DevicesBoston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Galt Medical Corporation
FDA DevicesClass II
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Aug 19, 2026Galt Medical Corporation
Medical DeviceFDA Devices
FDA DevicesBaxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter Healthcare Corporation
FDA DevicesClass I
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Aug 19, 2026Baxter Healthcare Corporation
Medical DeviceFDA Devices
FDA DevicesSurgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Covidien, LP
FDA DevicesClass II
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Aug 19, 2026Covidien, LP
Medical DeviceFDA Devices
FDA DevicesCardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
Cardinal Health 200, LLC
FDA DevicesClass II
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Aug 19, 2026Cardinal Health 200, LLC
Medical DeviceFDA Devices
FDA DevicesV-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246
Covidien, LP
FDA DevicesClass II
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Aug 19, 2026Covidien, LP
Medical DeviceFDA Devices
FDA DevicesMedline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Industries, LP
FDA DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Aug 19, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesThermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Remel Europe Ltd.
FDA DevicesClass II
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Aug 19, 2026Remel Europe Ltd.
Medical DeviceFDA Devices
FDA DevicesGORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
W L Gore & Associates, Inc.
FDA DevicesClass II
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Aug 19, 2026W L Gore & Associates, Inc.
Medical DeviceFDA Devices
FDA DevicesBOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
MICROVENTION INC.
FDA DevicesClass II
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
Due to an increase rate of balloon pinhole defects.
Aug 19, 2026MICROVENTION INC.
Medical DeviceFDA Devices
FDA DevicesCardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health 200, LLC
FDA DevicesClass II
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Aug 19, 2026Cardinal Health 200, LLC
Medical DeviceFDA Devices
FDA DevicesCardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63
Cardinal Health 200, LLC
FDA DevicesClass II
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Aug 19, 2026Cardinal Health 200, LLC
Medical DeviceFDA Devices
FDA DevicesAllura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Firmware issue potentially leading to loss of geometry movements.
Aug 19, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceFDA Devices
FDA DevicesBrand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Spectra Medical Devices, Llc
FDA DevicesClass I
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
Aug 19, 2026Spectra Medical Devices, Llc
Medical DeviceFDA Devices
FDA DevicesPhilips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Aug 19, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.