Medical Device Recalls

728333 Spectral CT 7500 -Computed Tomography X-ray system

Philips North America Llc

Epix Universal Clip Applier, REF: CA500, STERILEEO

Applied Medical Resources Corp

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5

Smiths Medical ASD Inc.

Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Numbe

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product De

THOR Photomedicine Ltd

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number

MEDLINE INDUSTRIES, LP - Northfield

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.