Medical Device Recalls

Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Beckman Coulter Biomedical GmbH

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E

Medtronic Neurosurgery

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calcula

Staar Surgical AG

Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended

Siemens Medical Solutions USA, Inc

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

Becton Dickinson & Company

BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01

CareFusion 303, Inc.

Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC810

MEDLINE INDUSTRIES, LP - Northfield

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

Medtronic Neuromodulation

Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ

B. Braun Medical, Inc.

Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Merit Medical Systems, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001380;

Beaver Visitec International, Inc.

DeRoyal PAIN TRAY, REF 89-10464.02

DeRoyal Industries Inc

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Sonendo Inc

Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i

ROUTE 92 MEDICAL INC

Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88

Waldemar Link GmbH & Co. KG (Mfg Site)

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:

Integra LifeSciences Corp.

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

ICU Medical, Inc.

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02

Linkbio Corp.

Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and Co

GE Medical Systems Information Technologies Inc

GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.

GE Medical Systems China Co., Ltd.

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Beaver Visitec International, Inc.

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides

Integra LifeSciences Corp.

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring do

Landauer

WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

Boston Scientific Corporation

Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc

Fujirebio Diagnostics, Inc.

Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pr

CooperSurgical, Inc.