Medical Device Recalls

Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU C

MEDLINE INDUSTRIES, LP - Northfield

Breast Abdominoplasty Pack

American Contract Systems, Inc.

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

Becton Dickinson & Co.

Adrenal Test

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FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

ConvaTec, Inc

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W

Augustine Temperature Management, LLC

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab

Baxter Healthcare Corporation

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

Angiodynamics, Inc.

TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo

Howmedica Osteonics Corp.

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Produ

Alcon Research LLC

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8

Becton Dickinson & Company

Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev

Philips North America Llc

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202

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SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

TEI Biosciences, Inc.

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep

Randox Laboratories Ltd.

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Pro

Angiodynamics, Inc.

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

Fresenius Medical Care Renal Therapies Group, LLC

Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing

MEDLINE INDUSTRIES, LP - Northfield

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod

Ortho-Clinical Diagnostics, Inc.

CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in

CardioFocus, Inc.

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with c

Mindray DS USA, Inc. dba Mindray North America

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Staar Surgical Company

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

LSL Healthcare Inc.

DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

Angiodynamics, Inc.

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,

ARROW INTERNATIONAL Inc.

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ

Integra LifeSciences Corp.

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

Hobbs Medical, Inc.