Medical Device Recalls

EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adult

Olympus Corporation of the Americas

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification

Abbott Molecular, Inc.

DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711

Howmedica Osteonics Corp.

ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin Ma

Pro-Dex Inc

GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

Wipro GE Healthcare Private Ltd.

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

TMJ Solutions Inc

BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

Becton Dickinson & Co.

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041

Cardinal Health

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for bl

Maquet Medical Systems USA

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only;

TELEFLEX LLC

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

MEDLINE INDUSTRIES, LP - Northfield

Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t

Cook Incorporated

Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 505

Stryker Medical Division of Stryker Corporation

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

Hobbs Medical, Inc.

S8-3t Transducer Probe

Philips Ultrasound, Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;

Beaver Visitec International, Inc.

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item

Exactech, Inc.

Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain

The Metrix Company

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000479;

Beaver Visitec International, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;

Beaver Visitec International, Inc.

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

Intuitive Surgical, Inc.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14

Linkbio Corp.

Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

Stradis Healthcare

PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

TEI Biosciences, Inc.

CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS

Medline Industries, LP

Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18

AVID Medical, Inc.

See RES description

MEDLINE INDUSTRIES, LP - Northfield

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

Linkbio Corp.