Medical Device Recalls

BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02

Flexicare Medical (Dongguan) Ltd.

DeRoyal EYE TRAY, REF 89-4957.08

DeRoyal Industries Inc

Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu

Siemens Healthcare Diagnostics, Inc.

Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

Boston Scientific Corporation

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9

Medline Industries, LP

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

American Contract Systems Inc

Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09

AVID Medical, Inc.

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152.

Cook Incorporated

FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5

Getinge Usa Sales Inc

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the

Shanghai United Imaging Healthcare Co., Ltd.

REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx On

Becton Dickinson Infusion Therapy Systems Inc.

SHIMADZU RF.004, Mobile X-ray system

SEDECAL SA

DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port f

Smiths Medical ASD Inc.

HemosIL LMW Heparin Controls; Part Number: 0020300200;

Instrumentation Laboratory

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicat

Zimmer, Inc.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-235

Sklar Instruments

CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

CardioQuip, LLC

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv

Remel, Inc

Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

Stryker Corporation

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

MEDLINE INDUSTRIES, LP - Northfield

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

Abbott

Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

3D9-3v Transducer Probe

Philips Ultrasound, Inc

Fixone Hybrid Anchor

Aju Pharm Co., Ltd.

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)

Smiths Medical ASD Inc.

Ami HTX.

Spectral Instruments Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;

Beaver Visitec International, Inc.

Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Co

Thoratec LLC

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Roche Diabetes Care, Inc.