Medical Device Recalls

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA21

Philips Respironics, Inc.

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

MEDLINE INDUSTRIES, LP - Northfield

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Cardinal Health

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Olympus Corporation of the Americas

Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc

Medical Action Industries, Inc. 306

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (M

Fujifilm Irvine Scientific, Inc.

Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY

Hobbs Medical, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;

Beaver Visitec International, Inc.

The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emissi

BigTree Sales Inc.

Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

Integra LifeSciences Corp. (NeuroSciences)

nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTA

Landauer

Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

Wondfo USA Co Ltd

GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

GE HEALTHCARE AUSTRIA GMBH & CO

BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II,

Becton, Dickinson and Company, BD Biosciences

Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

Micro Therapeutics, Inc.

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupli

Lumenis, Inc.

Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen

Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Tandem Diabetes Care Inc

MICRO-X Rover Mobile X-ray System, # MXU-RV35

Micro-X Ltd.

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a

Stryker Corporation

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intra

Fresenius Kabi USA, LLC

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Johnson & Johnson Surgical Vision Inc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter

Boston Scientific Corporation

18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Ass

Insulet Corporation

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri

Instrumentation Laboratory

Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

Medivance Inc.

CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

Diagnos Inc

Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN

ARROW INTERNATIONAL, LLC

WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal

Boston Scientific Corporation