Browse Device Recalls

905 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 905 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 905 FDA device recalls in 2026.

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DateProductReasonClassFirm
Feb 18, 2026 Cub Pediatric Crib, Model FL19H Cribs sold in the USA are missing two access door warning labels. Class II Stryker Medical Division of Stryker Corporation
Feb 18, 2026 Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Pe... Due to adapter not being properly aligned or locked in place. Class II Elekta, Inc.
Feb 17, 2026 See Luer Cap Set, MPC-130, set, administration, intravascular Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer C... Class II Molded Products Inc
Feb 16, 2026 MEDLINE ANTERIOR HIP PACK DYNJ64672B Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK,... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DY... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Automated Impella Controller (AIC), labeled as the following with correspondi... Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... Class I Abiomed, Inc.
Feb 16, 2026 Airway Exam Kit, DYKE1796 Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 THORACIC ROBOTS, DYNJ908777B Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Feb 16, 2026 Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm Drainable large pouch may leak due to manufacturing issue. Class II ConvaTec, Inc
Feb 13, 2026 MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, ... All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, ... All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, ... All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 MiniMed 530G Insulin Pump (MMT-551, MMT-751) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... Class II Medtronic MiniMed, Inc.
Feb 13, 2026 ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC Connectors were not manufactured to required dimensional specifications and may not form a proper... Class II Medline Industries, LP
Feb 13, 2026 Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE C... Connectors were not manufactured to required dimensional specifications and may not form a proper... Class II Medline Industries, LP
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 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

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.