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Browse Device Recalls

2,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,419 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 2,419 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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.
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 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.
Sep 8, 2025 ICU Medical ChemosafeLock Connecter REF: KL-FNU3 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, Bulk, Non-Sterile REF: CL2100-NS 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 w/Spiros, Red Cap REF: CL-35 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 w/Skirt, 5 Units REF: CL-80S-5 Port weld of drug transfer device may separate or break during use and potentially result in a l... Class II ICU Medical, Inc.
Aug 29, 2025 DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressi... Wound dressing may have foreign matter on the product. Class II ConvaTec, Inc
Aug 29, 2025 ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound minia... Production assembly error resulting in the potential for reversed articulation, where moving the ... Class II ImaCor Inc.
Aug 26, 2025 GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... Reports of vascular graft delamination, which may lead to reduced access flow; cannulation diffic... Class II W L Gore & Associates, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 6, 2025 Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, cla... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and ... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... Class II SEASPINE ORTHOPEDICS CORPORATION
Aug 6, 2025 Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... 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.