FDA recall, , Moderate risk
AXP Processing Bag Set
AXP Processing Bag Set may release particulates into the sterile fluid path.
Recall ended Oct 21, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
ThermoGenesis Corp. is recalling the AXP Processing Bag Set, Model No. 8-5101, because particulates from the stopcock were found in the bag set, which may be released into the sterile, non-pyrogenic fluid path. The recall began March 24, 2026, and was added to the FDA's Enforcement Report on July 22, 2026.
The product was distributed domestically in Arizona, Ohio, California, and North Carolina, and internationally to direct customers in Canada and Australia, and to distributors in Asia, Europe, and the Middle East.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the model number and UPC listed under your product.
A UPC is the number printed under a barcode.
AXP Processing Bag Set
- Model number
- 8-5101
- UPC
- 0886368000305
- 280714
- 2025070020
- 280915
- 2025090020
- 281022
- 2025100001
- 281105
- 2025110001
- 281201
- 2025120001
Recall details
- Company began the recall
- Sold in
Domestic: Arizona, Ohio, California, North Carolina. International: Direct Customers; Canada, Australia, and Distributors; Asia, Europe, and the Middle East.
- Company
- Themogenesis Corp.
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98762
- Recall number
- B-0150-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Recall ended
Summary updated
