Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2021 | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion Sy... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System,... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover ... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Pr... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cove... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-08... | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 29, 2021 | Hays Ultrasound kit Item ID: H1000SE | No 510k for the product to be used in a natural or surgical opening to the body | Class II | Exact Medical Manufacturing, Inc. |
| Apr 28, 2021 | 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powd... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each int... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... | Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... | Class II | Medtronic Vascular, Inc. |
| Apr 28, 2021 | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R | An issue was identified where the software froze during processing of commands, which resulted in... | Class II | Randox Laboratories Ltd. |
| Apr 28, 2021 | The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage s... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 g... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 27, 2021 | Quanta System Sterile Optical Laser Fiber, single use | Product sterility is potentially compromised. | Class II | Quanta System, S.p.A. |
| Apr 27, 2021 | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intende... | Product is impacted by a thread profile defect due to a manufacturing issue. | Class II | Medtronic Sofamor Danek USA, Inc |
| Apr 27, 2021 | Olympus Sterile Optical Laser Fiber, single use and reusable | Product sterility is potentially compromised. | Class II | Quanta System, S.p.A. |
| Apr 27, 2021 | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) c... | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... | Class II | Circulatory Technology Inc. |
| Apr 27, 2021 | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... | Class I | Quidel Corporation |
| Apr 27, 2021 | Quanta System Sterile Optical Laser Fiber, reusable | Product sterility is potentially compromised. | Class II | Quanta System, S.p.A. |
| Apr 26, 2021 | REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Concerto User Interface Software provided with the following systems: (1) ... | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not u... | Class II | Xstrahl Limited |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatogr... | Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution ... | Class I | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the eva... | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. | Class II | Northeast Scientific Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. | Sterility issues; single use devices labeled as sterile may not have been adequately sterilized | Class II | Meta C.G.M. Spa |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, 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.