Medical Device Recalls

System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste

GE Medical Systems, LLC

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Luminex Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000056;

Beaver Visitec International, Inc.

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects ph

Edan Diagnostics

INZONE DETACHMENT SYSTEM, REF: M00345100950

Stryker Neurovascular

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Abbott Molecular, Inc.

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an

Qiagen Sciences LLC

InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Medtronic MiniMed, Inc.

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S

Windstone Medical Packaging, Inc.

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Medtronic Neuromodulation

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

VANTIVE US HEALTHCARE LLC

Pediatric care bed; Product Designation: KayserBett IDA;

KAYSERBETTEN GMBH & CO. KG

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Micro-X Ltd.

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

Intuitive Surgical, Inc.

CODMAN Disposable Perforator 11mm. Cranial Perforator.

Integra LifeSciences Corp. (NeuroSciences)

Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT S

Alcon Research, LLC

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S

Smiths Medical ASD Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter

Boston Scientific Corporation

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

Thera Test Laboratories, Inc.

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

B Braun Medical Inc

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to

ROi CPS LLC

Universal Nerve Block Tray Catalog Number: 9818

Busse Hospital Disposables, Inc.

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum

Siemens Healthcare Diagnostics, Inc.

See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT

Medline Industries, LP

Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

ROi CPS LLC

Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes

Jiangsu Shenli Medical Production Co., Ltd.

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

Philips North America

GEM Premier 5000 PAK; Part No. 00055360011.

Instrumentation Laboratory