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Channel: Medical Device Recalls since April 03, 2025
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Clorox Healthcare Holdings, LLC (dba HealthLink) - PSS Select medical...

PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

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Clorox Healthcare Holdings, LLC (dba HealthLink) - HealthLinkBIOPSY PUNCHES -...

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

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Clorox Healthcare Holdings, LLC (dba HealthLink) - ARGENT SURGICAL...

ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

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BRAEMAR, INC. - Lithium Thionyl nonrechargeable disposable battery pack -...

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

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BRAEMAR, INC. - Lithium Thionyl nonrechargeable disposable battery pack -...

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.

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Penlon, Ltd. - Penlon Sigma Delta Vaporizer - Class 2 Recall

Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

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The Anspach Effort, Inc. - Emax Consoles - Class 2 Recall

***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the...

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The Anspach Effort, Inc. - Emax Consoles - Class 2 Recall

***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free...

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The Anspach Effort, Inc. - Emax Consoles - Class 2 Recall

***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone...

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Philips Medical Systems (Cleveland) Inc - Brilliance CT 64, Ingenuity Core,...

Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce...

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Ortho-Clinical Diagnostics - VITROS 3600 Immunodiagnostic System - Class 2...

VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical...

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Ortho-Clinical Diagnostics - VITROS 4600 Chemistry System - Class 2 Recall

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest,...

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Ortho-Clinical Diagnostics - VITROS 5600 Integrated System - Class 2 Recall

VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,...

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Ortho-Clinical Diagnostics - VITROS 5,1 FS Chemistry System - Class 2 Recall

1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative,...

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Ortho-Clinical Diagnostics - ORTHO Assay Software (OAS) Server - Class 2 Recall

ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked...

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Merit Medical Systems, Inc. - Custom Procedural Trays - Class 2 Recall

Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used...

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Siemens Medical Solutions USA, Inc - Siemens MEVATRON series, PRIMART...

Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS"...

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DJO, LLC - AIRCAST VENAFLOW ELITE SYSTEM - Class 2 Recall

VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

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SpineFrontier, Inc. - SLIFT - Class 2 Recall

S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body...

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SpineFrontier, Inc. - SLIFT - Class 2 Recall

BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants...

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