Medical Devices Recalls

Ami HTX.

Spectral Instruments Inc

UROSKOP Omnia Max. Model Number: 10762473

Siemens Medical Solutions USA, Inc

SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415

Chamberlain Technologies LLC

FDA Devices Critical Jun 25, 2025

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasm…

Diagnostica Stago, Inc.

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)

Dexcom, Inc.

FDA Devices Critical Jun 25, 2025

Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK…

Dexcom, Inc.

Lago X

Spectral Instruments Inc

SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030

Chamberlain Technologies LLC

Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: …

Guangzhou Pluslife Biotech Co., Ltd.

SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030

Chamberlain Technologies LLC

Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous…

Preat Corp

ICU Medical Plum Solos, Item number 400011001; infusion pump

ICU Medical, Inc.

FDA Drug Moderate Jun 18, 2025

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT …

BALT USA, LLC

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: …

Ascend Laboratories, LLC

FDA Drug Moderate Jun 18, 2025

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: …

Ascend Laboratories, LLC

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/device…

GE Medical Systems, LLC

Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM …

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

Fresenius Kabi USA, LLC

Intera 1.5T Achieva Nova-Dual Product Number: 781173;

Philips North America

Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Ada…

Microtek Medical, Inc.

Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description…

Tecfen Medical

BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

BD SWITZERLAND SARL

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus…

Microbiologics Inc

iBOT PMD with software version 01.05.24. Personal Mobility Device.

Mobius Mobility LLC

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Zyno Medical LLC

Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Rele…

MicroAire Surgical Instruments, LLC

Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-…

Olympus Corporation of the Americas

Azure S DR MRI SureScan, Product number W3DR01

Medtronic, Inc.

BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060

BD SWITZERLAND SARL

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planni…

QUANTUM SURGICAL SAS

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Remel, Inc

Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product…

Tecfen Medical

2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

Baxter Healthcare Corporation

Intera 1.5T Explorer/Nova Dual Product Number: 781108;

Philips North America

SmartPath to dStream for 1.5T¿; Product Number: 782146;

Philips North America

Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Zyno Medical LLC

Intera 1.5T Achieva IT Nova Product Number: 781175

Philips North America

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

Baxter Healthcare Corporation

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Cardinal Health 200, LLC

BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA

BD SWITZERLAND SARL

Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: Th…

Tecfen Medical

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Contamac Solutions, Inc.

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; Sma…

BD SWITZERLAND SARL

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

Stryker GmbH

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

Turncare, Inc

Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description…

Tecfen Medical

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Stryker GmbH

BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

Copan Italia