Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing
Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices used in critical cardiac procedures. The failure to perform endotoxin testing on devices labeled as non-pyrogenic represents a significant risk of harm, as endotoxins can cause serious complications in invasive medical procedures. No illnesses or injuries have been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling approximately 6,653 Custom Perfusion kits across 48 different models. These medical devices are used in cardiac perfusion procedures.
The recalled kits are labeled as non-pyrogenic, meaning they are represented as free from fever-causing endotoxins. However, endotoxin testing was not performed on these products before they were distributed, representing a failure in the required quality control process.
The kits have been distributed to healthcare facilities in the United States and internationally, including Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, and Spain. Within the US, distribution includes Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Kentucky, Massachusetts, Maine, Mississippi, New York, Ohio, Rhode Island, Tennessee, Texas, and Virginia.
Healthcare providers should verify whether they have these devices by checking model numbers and lot numbers against the FDA recall notice. More detailed information is available from the FDA and Medtronic Perfusion Systems.
The recalled product
- Product
- Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- missing-endotoxin-testing
- endotoxin-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medtronic Perfusion Kits: 1. Model BB10Q85R
- (a) GTIN 00763000343057
- Lot Numbers: 219164410
- 220219784
- 220822136
- 222227252
- (b) GTIN 20763000343068
- Lot Numbers: 219822381
- 220104257 2. Model BB11C01R
- GTIN 00763000312190
- Lot Numbers: 218556144
- 218790882
- 219012584
- 219586019 3. Model B7H95R22
- GTIN 00763000250904
- Lot Numbers: 219586008
- 220075503
- 220476338 4. Model BB7H95R25
- GTIN 00763000451738
- Lot Numbers: 221406421 5. Model BB7H99R22
Distribution
Distributed nationwide across the United States.
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