PlainRecalls

FDA Medical Devices

U.S. Food and Drug Administration — Medical device recalls

26,000 recalls · Page 24 of 520

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Moderate Aug 13, 2025

GYN ROBOTIC PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

LAP CHOLE PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Beckman Coulter, Inc.

Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

Beckman Coulter, Inc.

Moderate Aug 13, 2025

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Siemens Healthcare Diagnostics Inc

Moderate Aug 13, 2025

PACK GENERAL ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

LAVH PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

Beckman Coulter, Inc.

Moderate Aug 13, 2025

LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

Plum Duo Infusion System, List Number: 400020401

ICU Medical, Inc.

Moderate Aug 13, 2025

BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Becton, Dickinson and Company, BD Bio Sciences

Moderate Aug 13, 2025

PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U…

Flexicare Medical (Dongguan) Ltd.

Moderate Aug 13, 2025

LAPAROSCOPIC GYN. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

Flexicare Medical (Dongguan) Ltd.

Critical Aug 13, 2025

BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

Flexicare Medical (Dongguan) Ltd.

Moderate Aug 13, 2025

LAPAROSCOPIC TRAY. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

ROBOTIC URO/GYN PACK. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

Flexicare Medical (Dongguan) Ltd.

Moderate Aug 13, 2025

GYN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

BD Trucount Controls, 30 Test - REF: 340335

Becton, Dickinson and Company, BD Bio Sciences

Moderate Aug 13, 2025

GENERAL LAPAROSCOPY TRAY. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

B BRAUN MEDICAL INC

Moderate Aug 13, 2025

GEN LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

Beckman Coulter, Inc.

Moderate Aug 13, 2025

LAPAROSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

Critical Aug 13, 2025

BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2…

CareFusion 303, Inc.

Moderate Aug 13, 2025

MAJOR THORACOSCOPY BASIN. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

Moderate Aug 13, 2025

DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is indiv…

Nuclein LLC

Critical Aug 13, 2025

BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U …

Flexicare Medical (Dongguan) Ltd.

Moderate Aug 13, 2025

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

Beckman Coulter, Inc.

Critical Aug 6, 2025

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product …

Abiomed, Inc.

Moderate Aug 6, 2025

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics Inc

Critical Aug 6, 2025

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

Moderate Aug 6, 2025

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Philips North America

Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Fresenius Kabi USA, LLC

Moderate Aug 6, 2025

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Steris Corporation

Moderate Aug 6, 2025

BostonSight SCLERAL Lens

Boston Foundation For Sight

Moderate Aug 6, 2025

BostonSight PROSE Lens.

Boston Foundation For Sight

Moderate Aug 6, 2025

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Remel, Inc

Moderate Aug 6, 2025

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation

Moderate Aug 6, 2025

SmartPath to dStream for 3.0T Model Number (REF): 782145;

Philips North America

Moderate Aug 6, 2025

3M Ranger Irrigation Fluid Warming Set, REF 24750

3M Company

Moderate Aug 6, 2025

Ingenia 1.5T S Model Number (REF): 781347;

Philips North America

Moderate Aug 6, 2025

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

Microbiologics Inc

Moderate Aug 6, 2025

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

Philips North America

Critical Aug 6, 2025

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.