Medical Device Recalls

Constellation Procedure Pak

Alcon Research, LTD.

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Edwards Lifesciences, LLC

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 55

UIH Technologies LLC

BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C

Mckesson Medical-Surgical Inc. Corporate Office

YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.

Datascope Corp.

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins

Olympus Corporation of the Americas

D&C pack

American Contract Systems, Inc.

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

Howmedica Osteonics Corp.

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

MEDLINE INDUSTRIES, LP - Northfield

QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample

Qiagen GmbH

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-01

WISSNER-BOSSERHOFF GMBH

Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

Shirakawa Olympus Co., Ltd.

PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

ICU Medical, Inc.

Philips S4-1 Ultrasound Transducer

Philips Ultrasound, Inc

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

Atrium Medical Corporation

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Hologic, Inc.

Veradius Unity Mobile Surgery C-arm

Philips North America

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

Microbiologics Inc

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Bausch & Lomb Surgical, Inc.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Olympus Corporation of the Americas

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Medtronic Sofamor Danek USA Inc

Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.

Medline Industries, LP

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxyge

Nihon Kohden America Inc

CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

Zeltiq Aesthetics, Inc

MICRO-X Rover Mobile X-ray System, # MXU-RV19

Micro-X Ltd.

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10

ICU Medical Inc.

ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

Biomerieux Inc

Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s

Meridian Bioscience Inc