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
    • 2025070020
    • 2025090020
    • 2025100001
    • 2025110001
    • and 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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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 4:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.