Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.
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 3/5 (High).
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: The recall involves a medical device with a functional defect (leaking) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 41,052 units of the Stryker Ahto Tube Set with Tip Packaging, Catalog Number 0250070620. The recall affects units distributed worldwide, including the United States, Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The recall was initiated due to an increased amount of reported complaints consistently describing leaking from the handpiece during use. The source text does not specify any reported injuries, illnesses, or deaths associated with this defect.
Healthcare providers and consumers should stop using the affected devices and contact Stryker Corporation for further instructions or a replacement. The recall covers specific batch numbers and GTIN 07613327061659.
The recalled product
- Product
- STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 41,052
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)
- GTIN 07613327061659
- Batch Numbers: 24263FG2
- 24264FG2
- 24265FG2
- 24267FG2
- 24269FG2
- 24270FG2
- 24271FG2
- 24288FG2
- 24289FG2
- 24290FG2
- 24291FG2
- 24292FG2
- 24296FG2
- 24297FG2
- 24298FG2
- 24304FG2
- 24306FG2
- 24313FG2
- 24317FG2
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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