Medical Device Recalls

Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch record

Spacelabs Healthcare, Ltd.

ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.01

DNA Genotek Inc.

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

Cook Biotech, Inc.

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

Ethicon, Inc.

FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

B Braun Medical Inc

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

American Contract Systems Inc

DeRoyal CNRV SPINAL PACK, REF 89-10532.03

DeRoyal Industries Inc

STERILE STERILE PREP STICK, REF DYNDA1134

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584770;

Beaver Visitec International, Inc.

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v

Olympus Corporation of the Americas

Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Pos

Canon Medical System, USA, INC.

DeRoyal HEART PACK, REF 89-8351.13

DeRoyal Industries Inc

CombiDiagnost R90 Software Version R1.0 and R1.1

Philips Medical Systems Gmbh, DMC

WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

MICROVENTION INC.

Calibration Serum Level 3 CAL2351

Randox Laboratories Ltd.

Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Aniara Diagnostica LLC

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840

Siemens Healthcare Diagnostics, Inc.

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the brea

Draeger, Inc.

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Therakos, Inc.

I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

In2Bones, SAS

Centricity Radiology RA600

GE Healthcare, LLC

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

Haag-Streit USA Inc

Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

Cook Incorporated

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000781;

Beaver Visitec International, Inc.

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

MEDLINE INDUSTRIES, LP - Northfield

ST SENSE Breast Dx Coil

Philips North America Llc

MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

Medtronic MiniMed, Inc.

ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V

Siemens Medical Solutions USA, Inc.