Medical Device Recalls

Cardiac Workstation 5000; Model Number: 860439;

Philips North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;

Beaver Visitec International, Inc.

3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape

3M Healthcare Business

Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321

Hobbs Medical, Inc.

Procedural Accessory Kit Catalog Number: 9665R2

Busse Hospital Disposables, Inc.

Fixone Biocomposite Anchor

Aju Pharm Co., Ltd.

HeartWare HVAD Pump Accessories, REF MCS1753AK

Heartware, Inc.

Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (S

Mindray DS USA, Inc. dba Mindray North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001118;

Beaver Visitec International, Inc.

Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description:

Nova Ortho-Med Inc

Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

MEDLINE INDUSTRIES, LP - Northfield

Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

Abiomed, Inc.

Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the

Abiomed, Inc.

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular

Abiomed, Inc.

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon

Edan Diagnostics

VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to conta

The Metrix Company

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-

SD Biosensor, Inc.

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP

GE Medical Systems Information Technologies Inc

Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

PHILIPS HEADQUARTERS CAMBRIDGE

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NU

American Contract Systems Inc

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Philips Medical Systems Nederland B.V.

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syst

Philips North America

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Staar Surgical AG

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Fujifilm Irvine Scientific, Inc.

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

Boston Scientific Corporation

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,

Stradis Medical, LLC dba Stradis Healthcare

Freeman Pancreatic Flexi-Stent Catalog Number: 6584

Hobbs Medical, Inc.

Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3,

Edwards Lifesciences, LLC

Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM),

Carefusion 2200 Inc