Medical Device Recalls

BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿

Becton Dickinson & Co.

Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1

Beckman Coulter Inc.

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Onkos Surgical, Inc.

Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

MEDLINE INDUSTRIES, LP - Northfield

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ653

Medline Industries, LP

AirFit F30i Full Face Mask and User Guide

ResMed Ltd.

Inspire Model 3028, IV Implantable Pulse Generator

Inspire Medical Systems Inc.

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with

Onkos Surgical, Inc.

Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DE

ARROW INTERNATIONAL, LLC

ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

CareFusion 303, Inc.

Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr

Integrity Implants Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter

Boston Scientific Corporation

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 1920

Alcon Research LLC

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Foundation Medicine, Inc.

IntelliVue Patient Monitor MX550. Product Number: 866066.

Philips North America Llc

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxi

ETHICON, INC.

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

Olympus Corporation of the Americas

Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline Sw

MEDLINE INDUSTRIES, LP - Northfield

Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Nipro Medical Corporation

medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

Smiths Medical ASD, Inc.

OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center

Hill-Rom, Inc.

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. O

Cook Vandergrift, Inc.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CP

MEDLINE INDUSTRIES, LP - Northfield

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended fo

The Anspach Effort, Inc.

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

Mallinckrodt Manufacturing LLC