Medical Device Recalls

DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611

Howmedica Osteonics Corp.

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chil

Philips North America Llc

Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146

Cook Incorporated

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT

B. Braun Medical, Inc.

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection Sys

Magnolia Medical Technologies, Inc.

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified

Ortho-Clinical Diagnostics, INc.

Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS T

GOLD STAR DISTRIBUTION INC

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

DRG International, Inc.

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.

Smiths Medical ASD, Inc.

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Medline Industries, LP

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Universal Meditech Inc.

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Medtronic Vascular, Inc.

Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201

B Braun Medical Inc

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

Beckman Coulter, Inc.

Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr

TELEFLEX LLC

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades

Stryker Corporation

Ellume COVID-19 Home Test

ELLUME LTD

NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. siz

MALVERN PANALYTICAL LTD

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Encore Medical, LP

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123

Karl Storz Endoscopy

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Abbott Laboratories

BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

DeRoyal Industries Inc

Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-40

MEDLINE INDUSTRIES, LP - Northfield

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP

Qualigen Inc

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,

Siemens Medical Solutions USA, Inc

Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

AVID Medical, Inc.

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R

Accuray Incorporated

Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T

Medline Industries, LP