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Medtronic Perfusion Systems

Medtronic Perfusion Systems Recalls

All product recalls associated with Medtronic Perfusion Systems.

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Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3161–3180 of 10937 recalls

Medtronic Custom Perfusion Pack (Medtronic) – Weld Insufficiency (2021)

Specific lots may have been manufactured with insufficient or incomplete welds.

Moderate

FDAApr 29, 2021Nationwide• Medtronic Perfusion Systems

Ultrasound Kit (Exact Medical) – 510k Compliance Issue (2021)

No 510k for the product to be used in a natural or surgical opening to the body

Moderate

FDAApr 29, 2021FL, GA, MT +3 more• Exact Medical Manufacturing, Inc.

Medtronic Custom Perfusion Pack (Medtronic) – Weld Insufficiency (2021)

Specific lots may have been manufactured with insufficient or incomplete welds.

Moderate

FDAApr 29, 2021Nationwide• Medtronic Perfusion Systems

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Ultrasound Probe Cover (Exact Medical) – 510k Compliance Issue (2021)

No 510k for the product to be used in a natural or surgical opening to the body

Moderate

FDAApr 29, 2021FL, GA, MT +3 more• Exact Medical Manufacturing, Inc.

RX Imola Analyser (Randox) – Software Processing Issue (2021)

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

Moderate

FDAApr 28, 2021Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Quanta System Sterile Optical Laser Fiber (Quanta System) – Sterility Compromise (2021)

Product sterility is potentially compromised.

Moderate

FDAApr 27, 2021Nationwide• Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy

Braive Growth Modulation Screws (Medtronic) – Thread Profile Defect (2021)

Product is impacted by a thread profile defect due to a manufacturing issue.

Moderate

FDAApr 27, 2021IN• Medtronic Sofamor Danek USA, Inc

Olympus Sterile Optical Laser Fiber (Quanta System) – Sterility Compromise (2021)

Product sterility is potentially compromised.

Moderate

FDAApr 27, 2021Nationwide• Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy

Insignia Anterior Cervical Plate (Alphatec Spine) – Screw Blocking Risk (2021)

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Moderate

FDAApr 26, 2021Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble