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.

Clear
DateProductReasonClassFirm
Mar 28, 2023 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control dri... Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result... Class I Percussionaire Corporation
Mar 28, 2023 Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR Optical Trocars sterility assurance can not be guaranteed Class II Surgical Innovations Ltd
Mar 28, 2023 Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog ... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration da... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 28, 2023 YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR Optical Trocars sterility assurance can not be guaranteed Class II Surgical Innovations Ltd
Mar 27, 2023 GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: ... The product is brittle and potentially crumbling upon handling or when being removed from its pac... Class II Baxter Healthcare Corporation
Mar 27, 2023 Omnicell IVX Station-For use in the automated preparation of pharmaceutical a... IVX Station does not account for inherent scale inaccuracy or variability, could result in a prep... Class II OmniCell, Inc.
Mar 27, 2023 TDHisto/Cyto - A software product used for managing medical information in th... In a specific use case, when printing labels for slides, some labels may display wrong information Class II Technidata S.A.
Mar 27, 2023 Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended f... Marketed without a 510k Class II IMMUNDIAGNOSTIK, Inc
Mar 27, 2023 JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box incorrectly containing ... Class II Smith & Nephew, Inc.
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: ... A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy ... Class I Covidien
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... Class II Richard Wolf GmbH
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 23, 2023 WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (s... The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclo... Class II ASO LLC
Mar 22, 2023 VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 a... Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A... Class II Becton Dickinson & Co.
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS0101... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 STA R Max fully automatic clinical instrument designed to perform tests on hu... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 an... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and ... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR0... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS007... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000594 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E -... The recalling firm was notified by their supplier that the light handle covers may separate from ... Class II ROi CPS LLC
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000864 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical 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.