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 |
|---|---|---|---|---|
| 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.