Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 26 of 548
FDA Devices Critical Aug 6, 2025
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Draeger, Inc.
FDA Devices Moderate Aug 6, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Philips North America
FDA Devices Moderate Aug 6, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Fresenius Kabi USA, LLC
FDA Devices Moderate Aug 6, 2025
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions …
Volcano Corp
FDA Devices Moderate Aug 6, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 72202…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Aug 6, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
HeartSine Technologies Ltd
FDA Devices Moderate Aug 6, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved …
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Aug 6, 2025
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Philips North America
FDA Devices Moderate Aug 6, 2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Philips North America
FDA Devices Moderate Aug 6, 2025
Intera 3.0T Quasar Dual Model Number (REF): 781150;
Philips North America
FDA Food Critical Jul 30, 2025
Needle Mushrooms, Product of China, 200 gram packages, Plastic clear packaging on top with blue on the bottom (non-transparent). 25 packages per box .
LLK TRADING INC
FDA Devices Moderate Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KI…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software M…
Medtronic, Inc.
FDA Devices Moderate Jul 30, 2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Beckman Coulter Inc.
FDA Devices Moderate Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 30, 2025
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Stryker Corporation
FDA Devices Moderate Jul 30, 2025
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Olympus Corporation of the Americas
FDA Devices Moderate Jul 30, 2025
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El…
Olympus Corporation of the Americas
FDA Devices Moderate Jul 30, 2025
Biofinity XR Toric Contact Lens
CooperVision, Inc.
FDA Devices Moderate Jul 30, 2025
SIGNA Architect
GE Medical Systems, LLC
FDA Devices Moderate Jul 30, 2025
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Mod…
Medtronic, Inc.
FDA Devices Moderate Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 30, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 30, 2025
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus…
Olympus Corporation of the Americas
FDA Devices Moderate Jul 30, 2025
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
FDA Devices Moderate Jul 30, 2025
SIGNA Architect AIR
GE Medical Systems, LLC
FDA Devices Moderate Jul 30, 2025
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…
Olympus Corporation of the Americas
FDA Devices Moderate Jul 30, 2025
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…
Olympus Corporation of the Americas
FDA Devices Moderate Jul 30, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jul 30, 2025
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
CooperSurgical, Inc.
FDA Devices Moderate Jul 30, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Bridge to Life Ltd
CPSC Moderate Jul 24, 2025
Transpro US Recalls Electric Scooters with Unauthorized Lithium-Ion Battery UL Certification Labels Due to Fire and Burn Hazards; Risk of Serious Inj…
FDA Devices Moderate Jul 23, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Versi…
Encore Medical, LP
FDA Devices Moderate Jul 23, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
ICU Medical, Inc.
FDA Devices Moderate Jul 23, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra appl…
Medtronic, Inc.
FDA Devices Critical Jul 23, 2025
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Intersurgical Inc
FDA Devices Moderate Jul 23, 2025
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devic…
Waismed Ltd.
FDA Devices Moderate Jul 23, 2025
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devi…
Waismed Ltd.
FDA Devices Moderate Jul 23, 2025
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and pro…
NeuroSync, Inc.
FDA Devices Moderate Jul 23, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Versi…
Encore Medical, LP
FDA Devices Moderate Jul 23, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter, Inc.
FDA Devices Critical Jul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Baxter Healthcare Corporation
FDA Devices Moderate Jul 23, 2025
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Beyond Laser Systems, LLC
FDA Devices Moderate Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Versi…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Versi…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jul 23, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Beyond Laser Systems, LLC
FDA Devices Moderate Jul 23, 2025
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Ast…
Medtronic, Inc.
FDA Devices Critical Jul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Baxter Healthcare Corporation
CPSC Moderate Jul 17, 2025
Bexco Enterprises Recalls Kiwi Electronic Recliner and Swivel Gliders with USB Port Due to Overheating Hazard
Guangzhou Plenty Bicycle Co., Ltd., of China
CPSC Moderate Jul 17, 2025