Medical Device Recalls

SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.

MEDLINE INDUSTRIES, LP - Northfield

ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring

Mindray DS USA, Inc. dba Mindray North America

RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an

Acumed LLC

Mycoplasma test, IgG and IgM

GET TESTED INTERNATIONAL AB

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;

Beaver Visitec International, Inc.

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EB

Medline Industries, LP

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Maquet Cardiovascular, LLC

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

American Contract Systems Inc

BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

HANGZHOU BEVER MEDICAL DEVICES CO., LTD.

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Leica Microsystems, Inc.

FIRST RESPONSE 2 CT, SKU 902343

Family Dollar Stores, Llc.

Nerve Block Tray Catalog Number: 8415

Busse Hospital Disposables, Inc.

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

Siemens Healthcare Diagnostics, Inc.

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301

Biomet, Inc.

Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P

MEDLINE INDUSTRIES, LP - Northfield

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

B Braun Medical Inc

MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B

MEDLINE INDUSTRIES, LP - Northfield

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catal

Avanos Medical, Inc.

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/

Fresenius Medical Care Holdings, Inc.

Allura Xper FD10F; Model Number: 722002;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Biomet, Inc.

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.

RAYSEARCH LABORATORIES AB

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910

Howmedica Osteonics Corp.

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE

Olympus Corporation of the Americas

ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN

Siemens Healthcare Diagnostics, Inc.

Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019

GE Healthcare, LLC

RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio

RAYSEARCH LABORATORIES AB

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

ARROW INTERNATIONAL Inc.