Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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DateProductReasonClassFirm
Sep 1, 2023 Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Numb... Device reaching End of Service prematurely. Class II Angel Medical Systems, Inc.
Sep 1, 2023 Cath Cardiac Pack, REF IHCC03V During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Pediatric Heart SJH, REF SJPH34K During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 CVS PCSU SJH, REF SJCV48J During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-0... It has been found that potential unintended laser activation can occur without foot pedal depress... Class II Convergent Dental
Sep 1, 2023 Vasc. Open CVOR SJH, REF SJVO56B During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Robotics Pack, REF SJVO56B During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Robotics Pack SAH, REF SAR530M During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Sep 1, 2023 LAVH, REF BBLV21C During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Aug 31, 2023 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... The firm conducting a recall due to a complaint received indicating that a package contained a LE... Class II Smith & Nephew Inc
Aug 31, 2023 HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... Class II Access Vascular, Inc
Aug 31, 2023 HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... Class II Access Vascular, Inc
Aug 31, 2023 EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP Endobronchial implant devices may have been labeled with a shortened expiration date but they can... Class II Pulmonx, Corp.
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-200 Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 Citrine QTRAP Mass Spectrometer, Part Number 5063685 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 300900000000, Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-Z-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 API3200MD Mass Spectrometer, Part Number 4466230 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-100. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera... Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c... Class II RoyalVibe Health Ltd.
Aug 30, 2023 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 Citrine Triple Quad Mass Spectrometer, Part Number 5063684 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 29, 2023 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue,... Class II Limacorporate S.p.A
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision surgery. Class II Flower Orthopedics Corporation
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 ... There is the potential that the safety shield may not properly engage on IV catheters. The needle... Class II Becton Dickinson Infusion Therapy Systems Inc.
Aug 29, 2023 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... Class II CooperSurgical, Inc.
Aug 25, 2023 Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. Class II Beaver Visitec International, Inc.
Aug 25, 2023 Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ... Class II Immunostics, Inc.
Aug 25, 2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... Class I Philips Respironics, Inc.
Aug 25, 2023 Multichem P, Part Code 08P90-10 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 24, 2023 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Peripheral coil system detachable has a potential of unsealed pouch packaging. Class II MICROVENTION INC.
Aug 24, 2023 Various Medical Products stored on pallets, including but not limited to band... Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d... Class II Inmar Supply Chain Solutions, 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.