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Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

Clear
DateProductReasonClassFirm
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.
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.
Sep 6, 2025 Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. P... Potential for compromised integrity of the sterile packaging. Class II Iantrek Inc.
Sep 6, 2025 C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. ... Potential for compromised integrity of the sterile packaging. Class II Iantrek Inc.
Sep 5, 2025 Philips L12-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips C9-4 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X7-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips 3D6-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI III TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips Mini Multi TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips L17-5 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips OMNI II TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips X3-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S4-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Philips S5-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Sep 5, 2025 Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED... Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attac... Class II MICROVENTION INC.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 Brand Name: Branding is not applied to this product. Product Name: DVI displ... Due to display cables used for monitors were not in compliance with electromagnetic interference ... Class II Spacelabs Healthcare, Inc.
Sep 5, 2025 Brand Name: Branding is not applied to this product. Product Name: DVI displ... Due to display cables used for monitors were not in compliance with electromagnetic interference ... Class II Spacelabs Healthcare, Inc.
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.
Sep 5, 2025 Brand Name: Branding is not applied to this product. Product Name: DVI displ... Due to display cables used for monitors were not in compliance with electromagnetic interference ... Class II Spacelabs Healthcare, Inc.
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... Due to products that have not completed design updates and performance testing being released/dis... Class II Exactech, Inc.
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.

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.