Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
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.
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 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 Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GE... 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 ANSH14AF SHOULDER PACK ... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 4, 2025 Basic Biopsy Tray, Item Number NMBP44L 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 IHDC30R D AND C 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 Item number/ Product description AHLD15X LABOR ... 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 BUCY78E CYSTO PACK CMC... 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.
Sep 4, 2025 Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHA... Identified products were re-gassed (sterilized more than once) after a nonconformance occurred du... Class II American Contract Systems Inc.
Sep 3, 2025 Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagno... Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail c... Class II Beckman Coulter 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.