Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Feb 13, 2026 Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 Paradigm Insulin Pump (MMT-712, MMT-715) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 620G Insulin Pump (MMT-1750) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A,... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-17... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, C... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 12, 2026 Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 12, 2026 Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... Class II Olympus Corporation of the Americas
Feb 12, 2026 Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 12, 2026 Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: ... Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 11, 2026 TMJ Bilateral Implants, REF: CHG020 Custom temporomandibular joint implant may have contained incorrect patient-specific components t... Class II TMJ Solutions Inc
Feb 11, 2026 Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Kilt Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Caps. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Thyroid Shield. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Blockers. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Frontal Aprons Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Protective Sleeves. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Kilt Blockers. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Demi Half Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Vest Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Half Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Leg Wraps. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Burlington Medical, Wrap Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class II Burlington Medical, LLC
Feb 11, 2026 Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 11, 2026 Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 11, 2026 BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... Class II CareFusion 303, Inc.
Feb 10, 2026 Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAG... Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory respo... Class II Medline Industries, LP
Feb 10, 2026 Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product. Class II LeMaitre Vascular, Inc.
Feb 10, 2026 Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component... Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) Class II Orthalign, Inc
Feb 10, 2026 Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 componen... Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) Class II Orthalign, Inc
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Feb 9, 2026 RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... Class II Reflexion Medical, Inc.
Feb 9, 2026 Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... Class II Abbott Diagnostics Scarborough, Inc.
Feb 6, 2026 BD Kiestra" ReadA; Catalog No.: 446948. In certain situations, following a system reboot, one or more modules may have become unreachable... Class II BD KIESTRA LAB AUTOMATION
Feb 6, 2026 Battery Charging Station; Model: 0998-00-0802; The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ... Class III Datascope Corp.
Feb 6, 2026 Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR Software anomaly in the patient positioning system may result in positional discrepancy. Class II Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Artelon FlexBand Plus Ref: 41054 & 41057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) ... Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Software anomaly in the patient positioning system may result in positional discrepancy. Class II Hitachi, Ltd. Radiation Oncology Systems, Kashi...

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.