Browse Device Recalls
712 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 712 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 712 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Mar 1, 2021 | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "... | The kit does not have an emergency use authorization (EUA). | Class II | Cellex |
| Feb 18, 2021 | RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visual... | Teleflex is voluntarily recalling the products referenced above due to customers reporting that t... | Class II | TELEFLEX MEDICAL INC |
| Feb 12, 2021 | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... | Teleflex is recalling this product due to a lack of assurance of sterility. | Class II | TELEFLEX MEDICAL INC |
| Dec 23, 2020 | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
| Dec 23, 2020 | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con... | There is the potential of a bent or disconnected needle in one of the components of the convenien... | Class I | Combat Medical Systems, LLC |
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.