Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ... | Class II | Abbott |
| Mar 24, 2022 | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur... | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ... | Class II | Abbott |
| Mar 24, 2022 | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 23, 2022 | TearCare version 1.0 SmartHubs | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within... | Class II | Sight Sciences, Inc. |
| Mar 23, 2022 | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 23, 2022 | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. | Class II | Medtronic Vascular, Inc. |
| Mar 22, 2022 | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2... | Product not approved for release for US distribution | Class II | Steris Corporation |
| Mar 22, 2022 | ACS IR - Angio Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2... | Product not approved for release for US distribution | Class II | Steris Corporation |
| Mar 22, 2022 | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 22, 2022 | ACS Lap Chole Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | ACS Cath Lab Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 21, 2022 | Prevantics swabs and/or swabsticks contained inside the following Aligned Med... | Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional D... | Class II | Windstone Medical Packaging, Inc. |
| Mar 21, 2022 | ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0... | Software issue for treatment plan and image management application may result in mismatch values ... | Class II | Varian Medical Systems Imaging Laboratory GmbH |
| Mar 21, 2022 | Regard brand CABG Pack A and B - Spartanburg | Kits were packed into shipping boxes incorrectly. | Class II | ROi CPS LLC |
| Mar 21, 2022 | Avanos Cortrak 2 Enteral Access System (EAS) | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK ... | Class I | Avanos Medical, Inc. |
| Mar 21, 2022 | WAVES WCM Kidney Cassette Module | There is a potential for the WCM cassette pump head leaking solution. | Class II | Waters Medical Systems LLC |
| Mar 21, 2022 | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator mode... | Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become det... | Class II | Breas Medical, Inc. |
| Mar 21, 2022 | Restrata, Part Number RWM1-2X2 | Misprinted expiration date on the shelf-box | Class II | Acera Surgical Inc |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Mar 18, 2022 | Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl... | Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Hea... | Class II | Clinician's Choice Dental Products Inc. |
| Mar 18, 2022 | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time... | GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an... | Class II | Olympus Corporation of the Americas |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: regard Clinical Packaging ... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Mar 18, 2022 | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in ... | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of de... | Class II | Hologic, Inc |
| Mar 17, 2022 | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Su... | As a result of complaint data review, it identified tissue pushout events occurring during firing... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics ... | Class II | Stanbio Laboratory, LP |
| Mar 16, 2022 | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device... | Users received sample collection kits that were assigned to another user. Incorrect shipping lab... | Class II | LetsGetChecked Inc. |
| Mar 16, 2022 | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during catar... | High friction of the slider can cause the device to stick, or not move as intended. | Class II | Carl Zeiss Meditec AG |
| Mar 16, 2022 | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 310101... | Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test i... | Class II | GE Healthcare, LLC |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | PrisMax System, Product Code 955626 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | PrisMax System, Product Code 955724 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves | Product was distributed without being sterilized. | Class II | Cardinal Health 200, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAU... | Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an I... | Class II | Neuralynx Inc |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Cub 2 Enclosed Bed Canopy System | Due potential misuse of the product, firm is updating warnings and precautions booklet for produc... | Class I | Sensory Medical Inc |
| Mar 14, 2022 | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 11, 2022 | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Abbott Vascular |
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.