Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Philips North America
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. ...
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Numbe...
Medical Devices·64 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model...
Medical Devices·7 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Medical Devices·3 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model ...
Medical Devices·103 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Nu...
Medical Devices·22 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Medical Devices·1 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Numbe...
Medical Devices·54 affected·Apr 14, 2026
High RiskFDA
Philips North America
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Medical Devices·25 affected·Apr 14, 2026
High RiskFDA
Physio-control, Inc.
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-00...
Medical Devices·206 affected·Apr 13, 2026
High RiskFDA
Becton Dickinson & Co.
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Medical Devices·25,760 affected·Apr 7, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Medical Devices·0 affected·Apr 2, 2026
High RiskFDA
Abbott Point Of Care Inc.
i-STAT G3+ cartridge; List Number: 03P78-26;
Medical Devices·40,275 affected·Apr 1, 2026
High RiskFDA
Abbott Point Of Care Inc.
i-STAT EG7+ cartridge; List Number: 03P76-25;
Medical Devices·369,650 affected·Apr 1, 2026
High RiskFDA
Erbe Medical, Llc
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus ...
Medical Devices·260,962 affected·Mar 31, 2026
High RiskFDA
Boston Scientific Corporation
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Medical Devices·2 affected·Mar 30, 2026
High RiskFDA
Boston Scientific Corporation
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER ...
Medical Devices·148 affected·Mar 30, 2026
High RiskFDA
Micro-x Ltd.
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Medical Devices·32 affected·Mar 27, 2026
High RiskFDA
Spacelabs Healthcare, Inc.
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A P...
Medical Devices·57 affected·Mar 26, 2026
High RiskFDA
Immuno-mycologics, Inc
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium...
Medical Devices·101 affected·Mar 26, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Medical Devices·2,089 affected·Mar 25, 2026
RecallFDA
Heraeus Medical Gmbh (dental Division)
Heraeus, PALAMIX uno. Material Number: 66057893.
Medical Devices·51,771 affected·Mar 25, 2026
CriticalFDA
Ventec Life Systems, Inc.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Medical Devices·42 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Medical Devices·8,936 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Medical Devices·741 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Medical Devices·2,143 affected·Mar 25, 2026
High RiskFDA
Orthorebirth Co Ltd
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Medical Devices·20 affected·Mar 25, 2026
RecallFDA
Heraeus Medical Gmbh (dental Division)
Heraeus, PALAMIX duo. Material Number: 66057897.
Medical Devices·1,125 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Medical Devices·808 affected·Mar 25, 2026
High RiskFDA
Orthorebirth Co Ltd
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Medical Devices·1,266 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Medical Devices·1,259 affected·Mar 25, 2026
High RiskFDA
Davol, Inc.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Medical Devices·1,622 affected·Mar 25, 2026
High RiskFDA
Olympus Corporation Of The Americas
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Medical Devices·8,994 affected·Mar 25, 2026
High RiskFDA
Remel, Inc
Yeastone Broth, 11ML, 10/BOX YY3462
Medical Devices·2,819 affected·Mar 24, 2026
High RiskFDA
Foundation Medicine, Inc.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tr...
Medical Devices·10 affected·Mar 24, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Medical Devices·490 affected·Mar 23, 2026
High RiskFDA
Gentuity, Llc
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Medical Devices·184 affected·Mar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Medical Devices·830 affected·Mar 23, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Medical Devices·3,360 affected·Mar 23, 2026
High RiskFDA
Medline Industries, Lp
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/P...
Medical Devices·4,225,160 affected·Mar 19, 2026