Medical Devices Recalls

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

AVID Medical, Inc.

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

AVID Medical, Inc.

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B490401…

DSAART LLC

Cardiosave Hybrid

Datascope Corp.

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product D…

Rocket Medical Plc

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Fresenius Kabi USA, LLC

5008X CAREsystem +CLiC +CDX;

Fresenius Medical Care Holdings, Inc.

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Produc…

Rocket Medical Plc

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Spe…

Copan Italia

Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product D…

Rocket Medical Plc

Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Si…

DSAART LLC

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012…

GE Medical Systems China Co., Ltd.

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

Cepheid

Zimmer Dermatome AN, Model/Catalog Number: 88710100

Zimmer Surgical Inc

Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 4…

DSAART LLC

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube …

Rocket Medical Plc

Amp Fit Recalls AMP Smart Fitness Machines Due to Laceration and Serious Injury Hazard

Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

Medline Industries, LP

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Datascope Corp.

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the…

Steris Corporation

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in th…

Steris Corporation

BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630

C.R. Bard Inc

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x…

Orthofix U.S. LLC

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

C.R. Bard Inc

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Imm…

Beckman Coulter, Inc.

Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS

Medline Industries, LP

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus F…

Cardinal Health 200, LLC

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pati…

Draeger, Inc.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Datascope Corp.

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

C.R. Bard Inc

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patie…

Draeger, Inc.

Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS

Medline Industries, LP

Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS

Medline Industries, LP

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Philips North America

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient …

Draeger, Inc.

Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, …

Orthofix U.S. LLC

CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F

Medline Industries, LP

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H…

Orthofix U.S. LLC

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

Bard Peripheral Vascular Inc

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

GE Medical Systems, LLC

IntelliVue MP90. Product Number: M8010A.

Philips North America Llc

Food Intolerance Test Small

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IntelliVue MP30. Product Number: M8002A.

Philips North America Llc

Vitamin D-Test

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Candida Test

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Organic Acids Profile Test Large

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Allergy Test IgE

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Allergy test Small

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IntelliVue Patient Monitor MX800. Product Number: 865240.

Philips North America Llc

GI Microbiome Profile XL

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