Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
What this means for you
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: This is an FDA Class II recall involving a medical device with a potential risk-of-harm where injury has not yet been reported. The leaking handpiece could compromise device function or sterility during use.
Plain-English summary
Stryker Corporation is recalling the STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640. The recall affects 2,739 units distributed worldwide, including the United States and countries such as Australia, Brazil, Canada, France, Germany, and others.
The recall is being initiated due to an increased number of reported complaints describing leaking from the handpiece during use. This leakage could potentially compromise device function or sterility.
Consumers who have purchased this product should stop using it immediately and contact Stryker Corporation for a replacement or refund. The affected units are identified by batch numbers including 24284FG2, 24289FG2, 24313FG2, and others listed in the FDA recall notice.
The recalled product
- Product
- STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
- Manufacturer
- Stryker Corporation
- Affected units
- 2,739
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 (14)
- GTIN 07613327061475
- Batch Number: 24284FG2
- 24289FG2
- 24313FG2
- 24322FG2
- 24338FG2
- 24344FG2
- 24351FG2
- 25009FG2
- 25036FG2
- 25062FG2
- 25091FG2
- 25129FG2
- 25161FG2.
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.
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