Medical Device Recalls

BioZorb Marker. Radiographic soft tissue marker.

Hologic, Inc

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500

Instrumentation Laboratory

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

DEPUY (IRELAND)

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US So

Thoratec LLC

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

Hobbs Medical, Inc.

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

TELEFLEX LLC

GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur

Stryker Corporation

Design Options¿ / Epidural anesthesia kit (10 count carton)

B. Braun Medical, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

Boston Scientific Corporation

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC

Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292

Cardinal Health 200, LLC

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K

Merit Medical Systems, Inc.

Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabi

ZOLL Circulation, Inc.

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo

Prismatik Dentalcraft, Inc.

Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature

Trackx Technology Inc

PACK GENERAL ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP,

Medline Industries, LP

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Inspire Medical Systems Inc.

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Boston Scientific Corporation

Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYN

MEDLINE INDUSTRIES, LP - Northfield

Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

DAYE (ANNE'S DAY LTD)

3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape

3M Healthcare Business

ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators

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

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N

Smiths Medical ASD Inc.

CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU

Family Dollar Stores, Llc.

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03

Onkos Surgical, Inc.

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

Medline Industries, LP

Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232.

Philips North America Llc