Medical Device Recalls

SENSE Breast Coil

Philips North America Llc

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-

Exactech, Inc.

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectab

Carefree Surgical Specialties

DeRoyal PODIATRY PACK, REF 89-8359.13

DeRoyal Industries Inc

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

Baxter Healthcare Corporation

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contou

Meddev Corp

Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A;

Baxter Healthcare Corporation

CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US

Graphic Controls Acquisition Corporation

Endo-Model Replacement Plateau; Item Number: 15-0027/15;

Waldemar Link GmbH & Co. KG (Mfg Site)

DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Universal Meditech Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000628;

Beaver Visitec International, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model

MEDLINE INDUSTRIES, LP - Northfield

Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous jo

Biomet, Inc.

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND

Medline Industries, LP

Hemopro 2 with Vasoshield, Model VH-4001

Maquet Cardiovascular, LLC

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Produ

Angiodynamics, Inc.

Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A,

Versea Diagnostics LLC

CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

Philips North America LLC

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed

Northeast Scientific Inc.

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Treroto

Arrow International Inc

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp.

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:

Ferndale Laboratories, Inc.

Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY

Hobbs Medical, Inc.

MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA

MEDLINE INDUSTRIES, LP - Northfield

Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

Stryker Spine

STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,

Stradis Medical, LLC dba Stradis Healthcare

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascula

Cook Incorporated