Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
AXP Processing Bag Set, Model No. 8-5101
Themogenesis Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Themogenesis Corp. · 2890 Kilgore Rd · Rancho Cordova, CA · 95670-6151
Is this the product you have?
- AXP Processing Bag Set, Model No. 8-5101
- Lot codes and dates
- Model8-5101
- UDI(01)0886368000305(17)280714(10)2025070020 (01)0886368000305(17)280915(10)2025090020 (01)0886368000305(17)281022(10)2025100001 (01)0886368000305(17)281105(10)2025110001 (01)0886368000305(17)281201(10)2025120001
- Lot numbers
2025070020202509002020251000012025110001and 2025120001
- Amount recalled
- 5208
Where it was sold
Why it was recalled
ThermoGenesis is recalling AXP Processing Bag due to particulates from the stopcock being found in the bag set, which may be released into the sterile, non-pyrogenic fluid path.
This product could cause temporary or reversible health problems — stop using it.
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