Medical Device Recalls

Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF

Abbott Molecular, Inc.

Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B

Medline Industries, LP

Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod

MEDLINE INDUSTRIES, LP - Northfield

DREAMTOME 49-20MM/260CM Material Number: M00584000

Boston Scientific Corporation

MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hep

MEDLINE INDUSTRIES, LP - Northfield

EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a

Olympus Corporation of the Americas

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR M

MEDLINE INDUSTRIES, LP - Northfield

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile

GE Medical Systems, LLC

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Avanos Medical, Inc.

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm

F & A Foundation

ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device

Olympus Corporation of the Americas

Optima XR220amx, Mobile Digital-Ready Radiographic System

GE Medical Systems, LLC

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Gentherm Medical, LLC

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

IPG Medical Corporation

MOSAIQ Oncology Information System

Elekta, Inc.

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb

Medline Industries, LP

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.

Beaver Visitec International, Inc.

Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

AtriCure, Inc.

DeRoyal SPINE PACK, REF 89-8361.08

DeRoyal Industries Inc

LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the Li

XENEX Disinfection Services Inc.

BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074

Philips North America

Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

Medline Industries, LP

BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an

Becton Dickinson & Co.

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Olympus Corporation of the Americas

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

SURGICAL SPECIALTIES

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG

Luminex Corporation

BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield

Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi

SEASPINE ORTHOPEDICS CORPORATION

smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

Smiths Medical ASD Inc.