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Channel: Medical Device Recalls since April 03, 2025
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DePuy Spine, Inc. - CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT - Class 2 Recall

CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation...

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DePuy Spine, Inc. - CONFIDENCE SPINAL CEMENT SYSTEM KIT - Class 2 Recall

CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of...

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Boston Scientific Corporation - Boston Scientific, FlextomeTM Cutting...

Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue #...

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Boston Scientific Corporation - Boston Scientific, Small Peripheral Cutting...

Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of...

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MicroAire Surgical Instruments, LLC - Steinmann Pin - Class 2 Recall

Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd...

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MicroAire Surgical Instruments, LLC - KirschnerWire (KWire), - Class 2 Recall

Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand...

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Elekta, Inc. - Elekta DMLC - Class 2 Recall

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

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Medical Indicators, Inc. - Tempa DOT - Class 2 Recall

Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601...

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GE Healthcare, LLC - Tec 6 Plus Vaporizer - Class 2 Recall

Tec 6 continuous Flow Vaporizer and Tec 5 Plus Anesthesia Vaporizer The Tec 6 and Tec Plus is an electronic vaporizer which delivers The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an...

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B Braun Medical, Inc. - Outlook ES Safety Infusion System - Class 2 Recall

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is...

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B. Braun Medical, Inc. - B. Braun Outlook Safety Infusion System Burette Set...

Outlook Safety Infusion System Burette Set. For intravenous fluid administration.

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Baxa Corporation - Baxa Vial Adapter, 14mm Luer Lock - Class 2 Recall

Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

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B Braun Medical, Inc. - Outlook ES Safety Infusion System - Class 2 Recall

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is...

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Berchtold Corp. - OPERON D850 Surgical Table - Class 2 Recall

OPERON D850 Surgical Table Product Usage: Surgical Table

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Xlumena, Inc. - Xlumena brand NAVIX Access Device - Class 2 Recall

Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a...

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Leica Microsystems (Schweiz) Ag - Leica M720 OH5 - Class 2 Recall

Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical...

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Leica Microsystems (Schweiz) Ag - Leica M525 OH4 - Class 2 Recall

Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical...

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Covidien LLC - Class 2 Recall

Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes...

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Covidien LLC - Class 2 Recall

Monoject" 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes...

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Covidien LLC - Class 2 Recall

Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes...

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