Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2026 | Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Surgical light assembly may not adequate support the weight of the ceiling cover. | Class II | Stryker Communications |
| Feb 23, 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN):... | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the s... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 20, 2026 | Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly d... | Class II | Masimo Corporation |
| Feb 20, 2026 | Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly d... | Class II | Masimo Corporation |
| Feb 20, 2026 | Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL... | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Class II | Clariance-SAS |
| Feb 19, 2026 | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ... | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to... | Class II | AMO Puerto Rico Manufacturing, Inc. |
| Feb 18, 2026 | XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number ... | Units from one lot were mislabeled with an incorrect part number, identifying the device as a sho... | Class II | XTANT Medical Holdings, Inc |
| Feb 18, 2026 | Sterile Radiology Procedure Kits, Model Number DYNDH1491B | There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which m... | Class II | Medline Industries, LP |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... | Class II | Baxter Healthcare Corporation |
| Feb 18, 2026 | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog N... | Due to product exhibiting potential to generate either invalid or false negative results. | Class II | Hologic, Inc. |
| 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 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Mod... | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Encore Medical, LP |
| Feb 16, 2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Mod... | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Encore Medical, LP |
| 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 | 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 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 |
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.