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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

353

Class I (Serious)

Most Recent

Jan 2026

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 1461–1480 of 3680 recalls

Medtronic EVNP Clinical Pack (Medtronic) – Bacterial Endotoxin Risk (2021)

Laceration Risk

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

High

FDAFeb 4, 2021Nationwide• Medtronic Perfusion Systems

Medtronic Custom Perfusion Pack (Medtronic) – Bacterial Endotoxin Risk (2021)

Laceration Risk

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

High

FDAFeb 4, 2021Nationwide• Medtronic Perfusion Systems

Medtronic Affinity Pixie Oxygenator (Medtronic) – Bacterial Endotoxin Risk (2021)

Laceration Risk

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Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

High

FDAFeb 4, 2021Nationwide• Medtronic Perfusion Systems

Corin BIOLOX DELTA Mod Head 36mm (Corin) – Labeling Error (2021)

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

Low

FDAJan 25, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Corin BIOLOX DELTA Mod Head 32mm (Corin) – Labeling Error (2021)

Low

FDAJan 25, 2021Nationwide• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Kodama Ultrasound Catheter (Acist) – O-Ring Damage (2021)

Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.

Moderate

FDAJan 22, 2021Nationwide• Acist Medical Systems

OT1000 Surgical Tables (Steris) – Beam Separation Risk (2021)

On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.

Moderate

FDAJan 21, 2021AL, AK, AZ +37 more• Steris Corporation

Quantikine sTfR Immunoassay (R & D Systems) – Signal Inconsistency (2021)

R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.

Moderate

FDAJan 20, 2021CA, FL, LA +1 more• R & D Systems, Inc.

HeartSpan Transseptal Needles (Merit Medical) – Tip Curvature Mismatch (2021)

The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.

Moderate

FDAJan 19, 2021AL, CA, CT +15 more• Merit Medical Systems, Inc.

Bemer Pro-Set (BEMER) - Potential Electromagnetic Interference (2021)

There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.

Moderate

FDAJan 13, 2021Nationwide• BEMER INT. AG Austrasse 15 Triesen Liechtenstein