Medical Device Recalls

DeRoyal MAJOR ORTHO PACK, REF 89-9250.07

DeRoyal Industries Inc

VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib

Ortho-Clinical Diagnostics, Inc.

EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric an

Boston Scientific Corporation

FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring Sy

Abbott Diabetes Care, Inc.

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03;

Exactech, Inc.

Ventstar Coax 230, MP03376

Draeger Medical, Inc.

Liver Test

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BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno

Civco Medical Instruments Co. Inc.

XERF EFFECTOR 60. Electrosurgical unit.

Lutronic Corporation

Artis Q.zen ceiling, Model Number 10848354

Siemens Medical Solutions USA, Inc

Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Cathete

Cardinal Health 200, LLC

Veritas Advanced Infusion Packs, REF: VRT-AI

Johnson & Johnson Surgical Vision, Inc.

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro

Diagnostica Stago, Inc.

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251

SUMMA THERAPEUTICS, LLC

BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use

CareFusion 303, Inc.

ProCuity bed series, model number 3009, item number: 3009PX-Z-450.

Stryker Medical Division of Stryker Corporation

DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate post

DePuy Mitek, Inc., a Johnson & Johnson Co.

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS

MEDLINE INDUSTRIES, LP - Northfield

VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to conta

The Metrix Company

Bodor's I series laser cutting machine.

Jinan Bodor Cnc Machine Co Ltd

Freeman Pancreatic Flexi-Stent Catalog Number: 6535

Hobbs Medical, Inc.

Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03

Exactech, Inc.

BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

Miach Orthopaedics

Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807

Beaver Visitec International, Inc.

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Ortho-Clinical Diagnostics, Inc.

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

Zimmer, Inc.

Alcon Custom Pak Surgical Procedure Pack

Alcon Research, LLC

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA

Maquet Medical Systems USA

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K

Medline Industries, LP

Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

Spacelabs Healthcare, Inc.