Medical Device Recalls

60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or

B. Braun Medical, Inc.

EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and

Olympus Corporation of the Americas

Extended Tip Applicator, 8CM, Box of 5.

Integra LifeSciences Corp. (NeuroSciences)

HeartWare HVAD Pump Implant Kit, REF 1104

Heartware, Inc.

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

Heartware, Inc.

HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883

Stradis Medical, LLC dba Stradis Healthcare

SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an

Philips North America Llc

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

Whele LLC DBA Perch

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719

Medicrea International

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213

Cardinal Health 200, LLC

D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

Peter Lazic Gmbh

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

Beckman Coulter Inc.

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S

Synthes (USA) Products LLC

AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

Vyaire Medical

Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

C.R. Bard Inc

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4

Beckman Coulter Inc.

Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: Th

THOR Photomedicine Ltd

Fargo Ortho-K Lens

PARAGON VISION SCIENCES, Inc

Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following

DJO, LLC

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCP

Mentor Texas, LP.

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Natus Medical Incorporated

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER AC

Sterilmed, Inc.

Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211

Cardinal Health 200, LLC

Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L,

Penner Patient Care, Inc.

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca

Olympus Corporation of the Americas

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci

Siemens Healthcare Diagnostics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;

Beaver Visitec International, Inc.

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantati

CooperSurgical, Inc.