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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.