Browse Device Recalls
39,162 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,162 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 39,162 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.