Medical Device Recalls

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.0

Micromed S.p.A.

DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

Katalyst Surgical, LLC

ZAP-X Radiosurgery System

Zap Surgical Systems

AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pate

King Systems Corp. dba Ambu, Inc.

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T

Medtronic Sofamor Danek USA Inc

SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prost

Boston Scientific Corporation

C10-4ec Transducer Probe

Philips Ultrasound, Inc

Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS

MEDLINE INDUSTRIES, LP - Northfield

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

American Contract Systems Inc

Baxter Mobile column TruSystem 7500 U, Product Code 1730720

Baxter Healthcare Corporation

RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

Ossur H / F

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Stradis Healthcare

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

Stryker Corporation

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Intuitive Surgical, Inc.

MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.

Medline Industries, LP

ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re

Ambu Inc.

Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

Abiomed, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter

Boston Scientific Corporation

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125

Becton Dickinson & Co.

JAGTOME RX 39-30-260-025 Material Number: M00573100

Boston Scientific Corporation

Senographe Pristina

GE Medical Systems, SCS

BD BBL TB Stain Kit K, Catalog (REF): 212522

Becton Dickinson & Co.

DeRoyal MYELOGRAM PACK, REF 89-9304.06

DeRoyal Industries Inc

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Boston Scientific Neuromodulation Corporation

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Reichert, Inc.

Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite

Olympus Corporation of the Americas

Thoraguard Chest Tube Kit, 20 Fr

Centese Inc.

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P

W L Gore & Associates, Inc.