Browse Device Recalls

768 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 768 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 768 FDA device recalls in NC.

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DateProductReasonClassFirm
Mar 30, 2022 Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22... During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... Class II restor3d Inc.
Mar 30, 2022 Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the... Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. Class II restor3d Inc.
Mar 30, 2022 Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-2018101... During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... Class II restor3d Inc.
Mar 29, 2022 VITEK 2 Systems and VITEK 2 with MYLA. Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and syner... Class II bioMerieux, Inc.
Feb 9, 2022 VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. Invalid calibrations (out of range high) while using the product. Class II bioMerieux, Inc.
Feb 1, 2022 (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped... The folding boxes within the shipping case are mislabeled. The shipping case and immediate packa... Class II BSN Medical Inc
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containi... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (fin... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Dec 9, 2021 greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-... Some of the blood collection tubes show clotting due to variation of Lithium Heparin. Class II Greiner Bio-One North America, Inc.
Oct 14, 2021 These are communication systems, labeled as: a. NaviCare Nurse Call, Part Nu... An unrecoverable error may occur where a component will fail to complete the reboot cycle, become... Class II Hill-Rom Inc.
Sep 30, 2021 API 50 CH, Model 50300 There is potential to provide an incorrect organism identification. Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS SARS-COV-2 IgG, Ref 423834-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Mumps IgG (MPG), REF 30218 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Lyme IgM II (LYM), REF 416436 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS DEX@, Dimer Exclusion II, REF 30455-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Clostridium Difficile GDH, REF 30125-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Measles IgG (MSG), REF 30219 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS LH, REF 30406-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS PRG Progesterone, REF 30409-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Lyme IgG II (LYM), REF 417401 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS Estradiol II, REF 30431-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS SARS-COV-2 IgM, Ref 423833-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS FSH, REF 30407-01 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 22, 2021 VIDAS RUB IgG (RBG), REF 30226 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... Class II bioMerieux, Inc.
Sep 8, 2021 Kit: Central Line Dres Change 20/Cs The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. Class II Medical Action Industries, Inc. 306
Aug 20, 2021 Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75... Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. Class II Greiner Bio-One North America, Inc.
Aug 20, 2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Primary packaging labeling may be incorrect. Class II ConvaTec, Inc
Aug 18, 2021 COVENA PICC Sleeve Marketed without FDA clearance Class II Queen Comfort Products lLC
Aug 13, 2021 VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Blood collection tubes may experience a clotting issue. Class II Greiner Bio-One North America, Inc.
Aug 9, 2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressin... There is a potential for open seals which can compromise sterility. Class II ConvaTec, Inc
May 11, 2021 Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat,... There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, R... There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 novaplus, General Purpose Kit, Cat. No. 56603 There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: Blood Culture MAI Kit Part Number: 80076 Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: Injection REVIEW MAI Kit Part Number: 74736 Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: Midline Insertion DA. MAI Kit Part Number: 77981B Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: Blood Culture. MAI Kit Part Number: 80315D Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Mar 29, 2021 VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blu... VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw vo... Class II Greiner Bio-One North America, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.