RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,640 total recalls

Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr

Philips North America Llc

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr

Avanos Medical, Inc.

DeRoyal TRANS CANAL PACK, REF 89-7157.12

DeRoyal Industries Inc

LAP CHOLE PACK. Medical convenience kit.

AVID Medical, Inc.

BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.

Becton Dickinson & Co.

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

Philips North America

C8-4v Transducer Probe

Philips Ultrasound, Inc

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign

AMO Manufacturing USA, LLC

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

AVID Medical, Inc.

Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous

ZOLL Circulation, Inc.

SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

Mckesson Medical-Surgical Inc. Corporate Office

Zenition 50, Model #718096

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

OttLite Rechargeable UVC Disinfecting Wand

Ottlite TEchnologies, Inc.

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Icotec Ag

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be

Olympus Corporation of the Americas

Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes

Jiangsu Shenli Medical Production Co., Ltd.

REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOn

Becton Dickinson Infusion Therapy Systems, Inc.

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Fresenius Kabi USA, LLC

Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083

Baxter Healthcare Corporation

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in fac

MICROVENTION INC.

SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use i

Integra LifeSciences Corp.

GEM Premier 5000 PAK, Part No. 00055360004.

Instrumentation Laboratory

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Olympus Corporation of the Americas

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference

Cook Incorporated

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KI

Cardinal Health 200, LLC

JAGTOME RX 44-20-260-035 Material Number: M00573040

Boston Scientific Corporation

Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2

Medtronic Perfusion Systems

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483

Baxter Healthcare Corporation

GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

GE Medical Systems China Co., Ltd.

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Stryker, Inc.

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