Medical Device Recalls

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A;

Sklar Instruments

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

Whele LLC DBA Perch

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen

Bard Access Systems, Inc.

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc.

Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1

SunMed Holdings, LLC

Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.

Getinge Usa Sales Inc

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N

Dexcom, Inc.

CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

CardioQuip, LLC

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Smith & Nephew Inc.

Express Mini 500 Dry Seal Chest Drain, Part Number 16400

Atrium Medical Corporation

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Ve

ASP Global, LLC.

BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

Becton Dickinson & Co.

11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-

Karl Storz Endoscopy

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. S

Siemens Medical Solutions USA, Inc

Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description

Alcon Research LLC

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230

Becton Dickinson & Co.

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on

GE Medical Systems, LLC

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

Cordis US Corp

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an

Olympus Corporation of the Americas

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B;

MEDLINE INDUSTRIES, LP - Northfield

CRE Pro Wireguided 15-18mm 240cm

Boston Scientific Corporation

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-

Dexcom, Inc.

Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH

CareFusion 303, Inc.

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Philips North America

Burlington Medical, Kilt Blockers.

Burlington Medical, LLC

Hill-Rom Progressa Bed System

Baxter Healthcare Corporation

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

Erbe USA Inc

Insufflation unit, UHI-4.

Olympus Corporation of the Americas

Getinge Flow-c Anesthesia System, Part No. 6887700

Getinge Usa Sales Inc