Browse Device Recalls
726 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 726 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 726 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Jul 20, 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extr... | Class II | bioMerieux, Inc. |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| May 5, 2022 | Arrow Three-Lumen CVC | Gravity flow rates on the affected product lidstock are incorrect. | Class II | ARROW INTERNATIONAL Inc. |
| Apr 22, 2022 | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contai... | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, sk... | Class II | ConvaTec, Inc |
| Apr 11, 2022 | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Fle... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| Apr 11, 2022 | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-... | Reports received of torn corrugated breathing tubes. | Class II | TELEFLEX MEDICAL INC |
| 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 |
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.