Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | Optima NX; dual-head nuclear medicine gamma camera designed specifically for ... | 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 7000; Model Number: 860441; | 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 | Maxicam; dual-head nuclear medicine gamma camera designed specifically for ca... | 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 | Elscint Cardial; dual-head nuclear medicine gamma camera designed specificall... | 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 | Elscint Varicam; dual-head nuclear medicine gamma camera designed specificall... | 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 | Elscint SPX4; 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 | Millenium MPS; 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 | Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear med... | 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 | Elscint Helix; 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 9, 2025 | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build ... | Potential that the measured value may be smaller than the actual area. | Class II | MedicalCommunications GmbH |
| Sep 9, 2025 | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... | Class II | Biomet, Inc. |
| Sep 9, 2025 | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 8, 2025 | ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122... | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d... | Class II | Beckman Coulter, Inc. |
| Sep 8, 2025 | ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock"... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical ChemoLock Port REF: CL2100 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLoc... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA13... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLoc... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port R... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: C... | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | ICU Medical, Inc. |
| Sep 8, 2025 | ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 | Port weld of drug transfer device may separate or break during use and potentially result in a l... | Class II | 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.