Browse Device Recalls

5,540 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,540 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 5,540 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 30, 2025 MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 25, 2025 Artegraft¿ Collagen Vascular Graft; REF: AG1015; The device was incorrectly packed in the wrong size labeled outer packaging. Class II LeMaitre Vascular, Inc.
Sep 23, 2025 BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Aut... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 23, 2025 BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: ... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 23, 2025 BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX,... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 23, 2025 BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 23, 2025 BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 S... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 23, 2025 BD EpiCenter Microbiology Data Management System, labeled as the following: ... Product service credentials used by some BD technical support teams to access certain BD products... Class II Becton Dickinson & Co.
Sep 17, 2025 InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE PO... InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in f... Class II Enterix, Inc.
Sep 16, 2025 Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... Class II Medtronic Sofamor Danek USA Inc
Sep 16, 2025 Automated Impella Controller (AIC) labeled as the following with correspondin... Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... Class I Abiomed, Inc.
Sep 9, 2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... Class II Biomet, 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 2, 2025 Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) ... Due to incorrect product label (Incorrect product name identified on outer packaging). Class II Berkeley Advanced Biomaterials, LLC
Aug 28, 2025 Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... The product in incorrectly labeled. The label indicates that the skive hole should be above the b... Class II Boston Scientific Corporation
Aug 28, 2025 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... Class II Howmedica Osteonics Corp.
Aug 26, 2025 Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 26, 2025 Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 26, 2025 Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... Class II OSSTEM Implant Co., Ltd.
Aug 25, 2025 Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... Class II LeMaitre Vascular, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , R... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx ... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 21, 2025 Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx... Labeling includes shelf life that has not been validated. Class II Folsom Metal Products, Inc.
Aug 18, 2025 AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... Class II Aesculap AG
Aug 18, 2025 AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... Class II Aesculap AG
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 13, 2025 Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc

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.