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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.