Medical Device Recalls

SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

TEI Biosciences, Inc.

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep

Randox Laboratories Ltd.

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Pro

Angiodynamics, Inc.

Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing

MEDLINE INDUSTRIES, LP - Northfield

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod

Ortho-Clinical Diagnostics, Inc.

CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in

CardioFocus, Inc.

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with c

Mindray DS USA, Inc. dba Mindray North America

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Staar Surgical Company

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

LSL Healthcare Inc.

DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

Angiodynamics, Inc.

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,

ARROW INTERNATIONAL Inc.

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ

Integra LifeSciences Corp.

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

Hobbs Medical, Inc.

Medline Leg bag, REF URO12573

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA

MEDLINE INDUSTRIES, LP - Northfield

Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B

MEDLINE INDUSTRIES, LP - Northfield

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

DAYE (ANNE'S DAY LTD)

Various C-section packs

American Contract Systems, Inc.

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medl

Medline Industries, LP

SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

Townsend Design

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Olympus Corporation of the Americas

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

AtriCure, Inc.

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-

WANDERCRAFT SAS

Eye and Ear Dropper, Product Code 67082

Apothecary Products, LLC

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS9

MEDLINE INDUSTRIES, LP - Northfield

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away

Boston Scientific Corporation

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC

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

DRX Revolution Mobile X-Ray System

Carestream Health, Inc.

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24

Avanos Medical, Inc.

Philips S5-2 Ultrasound Transducer

Philips Ultrasound, Inc