Medical Device Recalls

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Boston Scientific Corporation

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10

Zimmer, Inc.

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa

Philips Respironics, Inc.

JAGTOME RX 39-20-450-025 Material Number: M00573090

Boston Scientific Corporation

REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01

Limacorporate S.p.A

The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in

Qualigen Inc

Impella LD intravascular micro axial blood pump, Product Number 005082

Abiomed, Inc.

PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Entopsis , Inc.

Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bon

Stryker Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417;

Beaver Visitec International, Inc.

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

Medtronic Inc.

Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

Remington Medical, Inc.

The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2

Quidel Corporation

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

ConvaTec, Inc

Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides health

Sarnova HC, Llc

Achieva XR, Magnetic Resonance System.

Philips North America Llc

Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30

MEDLINE INDUSTRIES, LP - Northfield

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Limacorporate S.p.A

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile,

Brius Technologies Inc.

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,

Cook Incorporated

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Draeger Medical, Inc.

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML o

Cytocell Ltd.

MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with

MRIMed Inc.

Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-R

American Nitrile Operations Llc

STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

Stradis Medical, LLC dba Stradis Healthcare

Pump 381 Pump Set (US); Product Code: 1000080;

Abiomed, Inc.

IntelliVue Patient Monitor MX850. Product Number: 866470.

Philips North America Llc

Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer

Abbott Laboratories

MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.

MEDLINE INDUSTRIES, LP - Northfield