Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 20 of 548
FDA Devices Moderate Sep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), RE…
Exactech, Inc.
FDA Devices Moderate Sep 24, 2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Sep 24, 2025
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 …
Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Sep 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not ap…
Agilent Technologies Denmark ApS
FDA Devices Moderate Sep 24, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Maquet Cardiovascular, LLC
FDA Devices Moderate Sep 24, 2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Folsom Metal Products, Inc.
FDA Devices Moderate Sep 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Beckman Coulter Inc.
FDA Devices Moderate Sep 24, 2025
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Medical Information Technology, Inc.
FDA Devices Moderate Sep 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Abbott Point Of Care Inc.
FDA Devices Moderate Sep 24, 2025
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Sep 24, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not a…
Agilent Technologies Denmark ApS
FDA Devices Moderate Sep 24, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Beckman Coulter Inc.
FDA Devices Moderate Sep 24, 2025
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Folsom Metal Products, Inc.
FDA Devices Moderate Sep 24, 2025
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Beckman Coulter Inc.
FDA Devices Critical Sep 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
FDA Devices Moderate Sep 24, 2025
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Folsom Metal Products, Inc.
CPSC Moderate Sep 18, 2025
IcyBreeze Cooling Recalls Portable Misting Fans Due to Fire Hazard
FDA Devices Moderate Sep 17, 2025
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Boston Scientific Corporation
FDA Devices Moderate Sep 17, 2025
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
WASATCH PHOTONICS
FDA Devices Moderate Sep 17, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Descriptio…
Encore Medical, LP
FDA Devices Moderate Sep 17, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Boston Scientific Corporation
FDA Devices Moderate Sep 17, 2025
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 17, 2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
Philips Medical Systems Nederland B.V.
FDA Devices Moderate Sep 17, 2025
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A…
Quest International, Inc.
FDA Devices Moderate Sep 17, 2025
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Quidel Corporation
FDA Devices Critical Sep 17, 2025
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts…
Olympus Corporation of the Americas
FDA Devices Moderate Sep 17, 2025
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Orthofix U.S. LLC
FDA Devices Moderate Sep 17, 2025
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
AVID Medical, Inc.
FDA Devices Moderate Sep 17, 2025
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
SEASPINE ORTHOPEDICS CORPORATION
FDA Devices Moderate Sep 17, 2025
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: En…
Encore Medical, LP
FDA Devices Moderate Sep 17, 2025
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Boston Scientific Corporation
FDA Devices Moderate Sep 17, 2025
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240…
Boston Scientific Corporation
FDA Devices Moderate Sep 17, 2025
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Omnia Medical
FDA Devices Moderate Sep 17, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: …
Encore Medical, LP
FDA Devices Moderate Sep 17, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
CORNEAT VISION, LTD.
FDA Devices Moderate Sep 17, 2025
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore…
Merit Medical Systems, Inc.
FDA Devices Moderate Sep 17, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material…
Encore Medical, LP
FDA Devices Moderate Sep 17, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. …
Boston Scientific Corporation
FDA Devices Critical Sep 10, 2025
IDM-MICRO-R. Electrical wheelchair component.
mo-Vis BVBA
FDA Devices Critical Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Medtronic Perfusion Systems
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
ICU Medical Inc.
FDA Devices Moderate Sep 10, 2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Visgeneer, Inc.
FDA Devices Moderate Sep 10, 2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog N…
Lumicell, Inc.
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Softwar…
RAYSEARCH LABORATORIES AB
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left …
Boston Scientific Corporation
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Ve…
RAYSEARCH LABORATORIES AB
FDA Devices Critical Sep 10, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version:…
Dexcom, Inc.
FDA Devices Moderate Sep 10, 2025
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum …
Integra LifeSciences Corp. (NeuroSciences)
FDA Devices Moderate Sep 10, 2025
Medshape Universal Joints, REF: DNE-9000-UJ
Medshape, INC.
FDA Devices Moderate Sep 10, 2025
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF…
Boston Scientific Neuromodulation Corporation