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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.