Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DrugsBD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Health CanadaTransport Canada Recall - 2026281 - FORD
Transport Canada Recall - 2026281 - FORD
Powertrain
Health CanadaTransport Canada Recall - 2026292 - LAND ROVER
Transport Canada Recall - 2026292 - LAND ROVER
Airbag
FDA DevicesCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
FDA DrugsBD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA DevicesMedline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Health CanadaTransport Canada Recall - 2026293 - WINNEBAGO INDUSTRIES
Transport Canada Recall - 2026293 - WINNEBAGO INDUSTRIES
Label
FDA Devices7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
FDA DevicesBrand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
FDA DevicesOmnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
FDA DevicesMEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
FDA Devices5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
FDA DevicesMedline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA DrugsBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA DevicesHillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
FDA DevicesA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA DevicesSolar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.
FDA DevicesA M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA Devices4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
FDA DevicesCRE Wireguided 12-15mm 240cm
CRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Health CanadaTransport Canada Recall - 2026309 - AIRSTREAM
Transport Canada Recall - 2026309 - AIRSTREAM
Electrical
FDA DevicesReprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
FDA Devices1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Germany BVLja! Beerenmischung, tiefgefroren, 750 Gramm Beutel
ja! Beerenmischung, tiefgefroren, 750 Gramm Beutel
Krankheitserreger