Medical Device Recalls

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design

Olympus Corporation of the Americas

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

Medline Industries, LP

Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R

CooperSurgical, Inc.

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Remel, Inc

Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of

Apellis Pharmaceuticals, Inc.

FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-pie

INTEGRATED MEDCRAFT LLC

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTI

MEDLINE INDUSTRIES, LP - Northfield

Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

Stryker Corporation

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Intuitive Surgical, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200

ICU Medical, Inc.

Welch Allyn Connex Vital Signs Monitor (CVSM):

Baxter Healthcare Corporation

LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067

Physio-Control, Inc.

BF-3C160: EVIS EXERA Bronchovideoscope

Olympus Corporation of the Americas

SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

PATH

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics

Ellex Medical Pty Ltd.

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8

Encore Medical, LP

myQA iON; Article Number: MQ10-000;

IBA Dosimetry GmbH

LABOR & DELIVERY PACK, Model Nos LLLD19H

American Contract Systems Inc

Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparos

Canadian Hospital Specialties Ltd.

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Advance Medical Designs, Inc.

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Zimmer Surgical Inc

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60

Hologic, Inc

X7-2 Transducer Probe

Philips Ultrasound, Inc

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Medline Industries, LP

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

Centurion FMS Pak

Alcon Research, LTD.

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL

Medline Industries, LP

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

New Standard Device Inc