Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 1, 2023 | Male-Female Midsection with the following sizes and model numbers. a. Male... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | General Pack, REF BBGP31C | 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 Urology Wolson Pack, REF BPPU55A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Breast Plastics Pack, REF BBPL20D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Sub Q Recorder Pack, REF BPRC87A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... | In some cases, when lubricating grease is present within the headband of the over-ear headphones... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2023 | Robotics Pack, REF SSRO22D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| 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. |
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.