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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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.

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DateProductReasonClassFirm
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 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 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" 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 MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 150995907205... Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. Class II Beckman Coulter, Inc.
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 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/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 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 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 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 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 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 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 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 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.
Sep 5, 2025 AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 Firm has identified a security vulnerability in AW Server products. If exploited, a malicious act... Class II GE Medical Systems, SCS
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 4, 2025 Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL L... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description RCEN25B ENT SDSC 024697... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MI... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... Class II Contego Medical LLC
Sep 4, 2025 Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 2... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item number/ Product description AKGN82E GENERA... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 XERF EFFECTOR 60. Electrosurgical unit. Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result... Class II Lutronic Corporation
Sep 4, 2025 Medical convenience kits Item Number/Description FHCP08Y C SECTION PK H... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Medical convenience kits Item Number/Description BFCT04X CATARACT PACK -... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems 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.