FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 45 of 520
Moderate Dec 25, 2024
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopi…
GE OEC Medical Systems, Inc
Moderate Dec 25, 2024
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Mint Medical GmbH
Critical Dec 25, 2024
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are de…
Kirwan Surgical Products, LLC
Moderate Dec 25, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo),…
Augustine Temperature Management, LLC
Critical Dec 25, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipol…
Kirwan Surgical Products, LLC
Moderate Dec 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the pat…
Spacelabs Healthcare, Ltd.
Moderate Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Critical Dec 25, 2024
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use i…
Kirwan Surgical Products, LLC
Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electri…
CooperSurgical, Inc.
Moderate Dec 25, 2024
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management, LLC
Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intend…
CooperSurgical, Inc.
Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Micro-X Ltd.
Moderate Dec 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Nu…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Dec 18, 2024
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Hologic, Inc
Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd.
Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Micro-X Ltd.
Moderate Dec 18, 2024
BD Pyxis CII Safe ES, REF: 1116-00
CareFusion 303, Inc.
Moderate Dec 18, 2024
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, …
Cardinal Health 200, LLC
Moderate Dec 18, 2024
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
CareFusion 303, Inc.
Moderate Dec 18, 2024
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Cardinal Health 200, LLC
Moderate Dec 18, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Noah Medical
Moderate Dec 18, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolo…
ICU Medical, Inc.
Moderate Dec 18, 2024
BD Pyxis MedStation ES, REF: 323
CareFusion 303, Inc.
Moderate Dec 18, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Diasorin Inc.
Moderate Dec 18, 2024
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Hermes Medical Solutions AB
Moderate Dec 11, 2024
Non-ablative Fractional Laser Systems, Model: WFB-01
WINGDERM ELECTRO-OPTICS LTD.
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4)…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
Ziehm Solo. Digital Mobile C-arm
Orthoscan, Inc.
Moderate Dec 11, 2024
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
Moderate Dec 11, 2024
Diode Laser Hair Removal model: WLA-01
WINGDERM ELECTRO-OPTICS LTD.
Moderate Dec 11, 2024
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Dec 11, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
Moderate Dec 11, 2024
Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare Diagnostics, Inc.
Moderate Dec 11, 2024
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Becton Dickinson & Co.
Moderate Dec 11, 2024
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Becton Dickinson & Co.
Moderate Dec 11, 2024
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wou…
Advanced Medical Solutions Ltd.