Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
Sep 12, 2025 Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifica... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Millenium MPR; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Cardiac Workstation 5000; Model Number: 860439; Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... Class II Philips North America
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... Class II UIH Technologies LLC
Sep 12, 2025 Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number:... Due to Users not having access to the Instructions for Use/User Manual due to it being password p... Class II Noah Medical Corporation
Sep 12, 2025 Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically f... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... Class II Medtronic Perfusion Systems
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 The failure occurs if a user on the Omnipod 5 iOS application selects and hol... The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual ... Class II Insulet Corporation
Sep 11, 2025 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 TENACIO Pump with InhibiZone; UPN: 72404429; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22... Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impac... Class II Theken Companies LLC
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection... The devices were shipped unsterilized. Class II Ethicon Endo-Surgery Inc
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 TENACIO Pump without InhibiZone; UPN: 72404420; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE ... The fastening post hardware could loosen allowing the fastening post to detach from the cot Class II Ferno-Washington Inc
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ... Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
Sep 11, 2025 EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Num... Medline has identified a limited quantity of saline IV flush syringes that may not meet the requi... Class II Medline Industries, LP
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 Medline Adult Anesthesia Set, REF DYNJ39985G Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due t... Class II Medline Industries, LP
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott

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.