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 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
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 Blue Ventilator Adapter Module, single-patient use circuit, Product Code M079... Urgent Medical Device Correction for the Volara system single-patient use circuit due to the pote... Class I Baxter Healthcare Corporation
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 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... Increased risk of purge leaks with Generation 1 purge cassettes. Class I Abiomed, Inc.
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 Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by ... If heating pad is folded while in use, the power density increases in the folded area causing exc... Class I Navajo Manufacturing Company
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 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

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.