Medical Device Recalls

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.

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWR

INTERVASCULAR, SAS

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.

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

Carefusion 2200 Inc

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312

Avanos Medical, Inc.

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product C

Abiomed, Inc.

Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-

TriMed Inc.

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

Angiodynamics, Inc.

Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)

Penumbra Inc.

BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment

Becton Dickinson & Company

DiagnosUS Pregnancy Test Midstream REF 100-17

Universal Meditech Inc.

3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape

3M Healthcare Business

The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol

Bard Peripheral Vascular Inc

HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chem

Mckesson Medical-Surgical Inc. Corporate Office