Stryker AHTO Tube Set Recalled for High Bioburden Levels
Stryker is recalling AHTO Tube Sets labeled sterile because routine testing found bioburden levels higher than internal acceptable rates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is identified through routine testing rather than reported adverse events, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Corporation is recalling specific lots of the Stryker Cassette Pump AHTO Tube Set. These products are labeled sterile but were found to have bioburden levels higher than internal acceptable rates during routine testing.
The recall involves 60,753 units total, including Model 0250070600 and Model 0250070620. The affected lots were distributed domestically and internationally to Australia and Mexico.
Healthcare facilities should stop using the affected lots and contact Stryker Corporation for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 60,753
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)
- a. Model 0250070600
- UDI 07613327061499
- Lot No. 17284FG2
- 17291FG2
- 17300FG2
- b. Model 0250070620
- UDI 07613327061659
- Lot No. 17275FG2
- 17279FG2
- 17280FG2
- 17282FG2
- 17283FG2
- 17284FG2
- 17285FG2
- 17286FG2
- 17289FG2
- 17292FG2
- 17293FG2
- 17297FG2
- 17298FG2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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