Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 6, 2025 | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... | Sync timeout may occur between the server and automated dispensing device, due to a server softwa... | Class II | CareFusion 303, Inc. |
| Feb 6, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component P... | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent sto... | Class II | Beckman Coulter, Inc. |
| Feb 6, 2025 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, M... | Devices may have higher than expected amounts of bacterial endotoxin. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 6, 2025 | THORACIC PACK , Model No UTTC82Y UTTC82AA-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | AV FISTULA , Model No UTAV77T | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | BORN ON ARRIVAL KIT , Model No LLBN11B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CYSTO PACK , Model N. HKCY31A | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CYSTO , Model No SACY80R | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LAPAROSCOPY PACK , Model No SFLA02A SFLA02B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DELIVERY PACK , Model No SGDV22D-01 SGDV22E | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DIAGNOSTIC NEURO IR TRAY , Model No WENE21 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, ... | Possibility for the obturator to break (separate). | Class II | Integra LifeSciences Corp. |
| Feb 6, 2025 | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | LABOR & DELIVERY PACK, Model Nos LLLD19H | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01... | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 5, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage error... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | IntelePACS (Image Fusion Module) - InteleViewer | A software application that receives digital images and data from various sources has a bug in sp... | Class II | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Feb 5, 2025 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Feb 5, 2025 | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX | There is the potential for missing motor mounting screws, which may have occurred during the serv... | Class I | Baxter Healthcare Corporation |
| Feb 5, 2025 | Access 2 Immunoassay Analyzer, Catalog Number 81600N | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alig... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (... | Entering multiple keys that trigger input simultaneously may remove data from first field of scre... | Class II | Medical Information Technology, Inc. |
| Feb 5, 2025 | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x... | Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce th... | Class I | Bard Peripheral Vascular Inc |
| Feb 5, 2025 | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... | Unexpected loose material in the male luer used in the aortic root cannula has been identified. P... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2025 | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... | Product is mislabeled with the incorrect fill volume. | Class II | Angiodynamics, Inc. |
| Feb 4, 2025 | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved th... | Class II | American Contract Systems Inc |
| Feb 3, 2025 | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients i... | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | Class II | Physio-Control, Inc. |
| Feb 3, 2025 | VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: ... | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause ... | Class I | Ventec Life Systems, Inc. |
| Feb 3, 2025 | HemosIL LMW Heparin Controls; Part Number: 0020300200; | Multiple complaints indicating lower than expected quality control (QC) results and in some insta... | Class II | Instrumentation Laboratory |
| Feb 3, 2025 | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400... | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared... | Class II | Beckman Coulter, Inc. |
| Feb 3, 2025 | Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS i... | Potential variability in calculations from fast array scans compared to array scans when operatin... | Class II | Medimaps Group |
| Feb 3, 2025 | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital S... | Due to issues associated with data migration of patient information and results to a Cloud servic... | Class II | St. Jude Medical |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig ... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Optima MR360, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tu... | Due to the inner diameter of the suction tubing connector being smaller than the suction canister... | Class II | DeRoyal Industries Inc |
| Jan 31, 2025 | Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat... | Sterility assurance with procedure trays | Class II | American Contract Systems, Inc. |
| Jan 31, 2025 | SIGNA MR380, NMRI system, Non-US Only | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover A... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap 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.