FDA Device Recalls

Class IITerminated

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

ARROW INTERNATIONAL Inc.

Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

September 14, 2022 · DeviceView details →

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

Alcon Clareon IOL with AutonoMe Delivery System

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06