Medical Device Recalls

Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

GE Healthcare Finland Oy

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental

STRATASYS LTD

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container cl

Becton Dickinson & Company

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

Philips North America

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

ICU Medical, Inc.

Precision CRF; Model Number: 706400;

Philips Medical Systems DMC GmbH

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG

MEDLINE INDUSTRIES, LP - Northfield

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

LeMaitre Vascular, Inc.

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

GE Medical Systems, LLC

ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as

Olympus Corporation of the Americas

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

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

Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch wi

MEDLINE INDUSTRIES, LP - Northfield

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000568;

Beaver Visitec International, Inc.

SM_40HF_B_D_VIR3, Mobile X-ray system

SEDECAL SA

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position

Baxter Healthcare Corporation

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814;

Sklar Instruments

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P

Waismed Ltd.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

ICU Medical, Inc.

Akkermansia Test

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Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent

SVS LLC

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130

Merit Medical Systems, Inc.

See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC

Medline Industries, LP

VL13-5 Transducer Probe

Philips Ultrasound, Inc

Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield