RecallHawk

Medical Device Recalls

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

13,633 total recalls

GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resona

GE Healthcare, LLC

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/U

Angiodynamics, Inc.

KNEE SCOPE Procedure tray Catalog Number: COKN48L

American Contract Systems Inc

Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B

ROi CPS LLC

Puritan Bennett 980 Series Ventilator

Medtronic formerly Covidien

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Baxter Healthcare Corporation

Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV

Medline Industries, LP

Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

MEDLINE INDUSTRIES, LP - Northfield

Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

AVID Medical, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

Boston Scientific Corporation

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tis

Mentor Texas, LP.

STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

Stradis Medical, LLC dba Stradis Healthcare

ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech r

Exactech, Inc.

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015

Stryker Corporation

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108

Hobbs Medical, Inc.

Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

MEDLINE INDUSTRIES, LP - Northfield

ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.

Siemens Medical Solutions USA, Inc.

Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.

Olympus Corporation of the Americas

BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111

Philips Respironics, Inc.

ARTIS icono ceiling. Model Number: 11328100.

Siemens Medical Solutions USA, Inc

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Cook Incorporated

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

Intuitive Surgical, Inc.

Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNEL

MEDLINE INDUSTRIES, LP - Northfield

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f

Fresenius Kabi USA, LLC

Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115

Medtronic Sofamor Danek USA Inc

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIAL

MEDLINE INDUSTRIES, LP - Northfield

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Ma

CooperSurgical, Inc.

CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786

GE Healthcare Finland Oy

GEM Premier 5000 PAK; Part No. 00055407508.

Instrumentation Laboratory

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,

ICU Medical, Inc.

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