Medical Device Recalls

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637

Covidien LP

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

ICU Medical, Inc.

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled

Dutch Ophthalmic USA, Inc.

Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended

Noah Medical

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;

Beaver Visitec International, Inc.

AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Co

Siemens Medical Solutions USA, Inc

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins

Olympus Corporation of the Americas

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36

Exactech, Inc.

MAGNETOM Verio. Model Number: 10276755.

Siemens Medical Solutions USA, Inc

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099

Datascope Corp.

Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

SEDECAL SA

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

Siemens Healthcare Diagnostics, Inc.

Pump Refill Kit Catalog Number: 7347R1

Busse Hospital Disposables, Inc.

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

Abbott

Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

Cordis US Corp

iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e)

Beckman Coulter, Inc.

PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

Biomerieux Inc

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Medline Industries, LP

XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS US

Baxter Healthcare Corporation

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

ARROW INTERNATIONAL Inc.

Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (O

CUE HEALTH INC

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hobbs Helical Retrieval Basket Catalog Number: 4806

Hobbs Medical, Inc.

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Olympus Corporation of the Americas

Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical int

Olympus Corporation of the Americas

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities

Tobii Dynavox Llc

ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950

Family Dollar Stores, Llc.

BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF:

BD SWITZERLAND SARL

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-

Exactech, Inc.