Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with reported issues affecting medical devices are classified as Severe (score 4).
Plain-English summary
Stryker Corporation is recalling its AHTO Tube Set Packaging, Catalog Number 0250070600, due to an increased number of reported complaints describing leaking from the handpiece during use. The GTIN for the product is 07613327061499, and the recall includes numerous batch numbers ranging from 24262FG2 to 25163FG2.
A total of 46,212 units are included in this recall. The product was distributed worldwide, covering US Nationwide distribution as well as the countries of 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 in reported complaints consistently describing leaking from the handpiece during use. No information regarding injuries or illnesses has been provided in the recall notice.
Healthcare facilities and users who have the affected AHTO Tube Set Packaging should follow their internal procedures for recalled medical devices and contact Stryker Corporation for further instructions. Consumers with questions can reference FDA recall number Z-2862-2026.
The recalled product
- Product
- STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Manufacturer
- Stryker Corporation
- Affected units
- 46,212
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 07613327061499
- Batch Numbers: 24262FG2
- 24263FG2
- 24264FG2
- 24266FG2
- 24267FG2
- 24268FG2
- 24269FG2
- 24283FG2
- 24284FG2
- 24286FG2
- 24287FG2
- 24288FG2
- 24289FG2
- 24290FG2
- 24291FG2
- 24292FG2
- 24293FG2
- 24294FG2
- 24295FG2
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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