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Browse Device Recalls

34,153 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,153 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 34,153 FDA device recalls — Class II.

Clear
DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 8, 2025 ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 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 Vented Vial Spike, 13mm REF: CL-72 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 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, 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 ChemoLock Bag Spike, 01 units REF: CL-10-10 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 ChemoLock Vented Vial Spike, 20mm REF: CL-70S 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 Bag Spike with Clave Additive Port REF: CL3940 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 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Grad... 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/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoL... 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 w/Mini Bag Spike ¿ REF: C-17 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 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, 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 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Conne... 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 13mm Closed Vial Spike REF: CL-82 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 31" (79 cm) Appx 3.4 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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connect... 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 Closed Vial Spike REF: CL-80 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/ChemoLock, ChemoLock Port REF: CL4136 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 Bag Spike REF: CL-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 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, ... 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 Bag Spike REF: KL-BS001U3 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 Double ChemoLock Port Syringe Transfer Set REF: CL-33 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 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 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 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 3.6 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 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 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 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 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 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.

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.