Medical Device Recalls

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical int

Olympus Corporation of the Americas

Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Beckman Coulter Biomedical GmbH

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS

MEDLINE INDUSTRIES, LP - Northfield

Unknown product

MEDLINE INDUSTRIES, LP - SPT

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Edwards Lifesciences, LLC

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT

MEDLINE INDUSTRIES, LP - Northfield

Pellet Insertion Tray Catalog Number: B1654

Busse Hospital Disposables, Inc.

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

New Medical Technologies Gmbh

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF

CareFusion 303, Inc.

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40

TEI Biosciences, Inc.

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump

ARROW INTERNATIONAL Inc.

Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

Parker Laboratories, Inc.

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Beckman Coulter, Inc.

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.

Hardy Diagnostics

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol

Instrumentation Laboratory

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001

Vyaire Medical

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g

Medtronic Neuromodulation

nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR re

Landauer

ICU Medical Plum Solos, Item number 400011001; infusion pump

ICU Medical, Inc.

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70

Channel Medsystems, Inc.

Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+

Stryker Neurovascular

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

Stryker Orthopaedics

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CH

Medline Industries, LP

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product

Olympus Corporation of the Americas

CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24,

Smiths Medical ASD Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive dis

Boston Scientific Corporation

Zimmer Dermatome AN, Model/Catalog Number: 88710100

Zimmer Surgical Inc

Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only

Abbott Medical

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.