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Moderate riskFDA DeviceClass II

Stryker AHTO dual spike tube sets recalled for reported handpiece leaking

Stryker is recalling AHTO dual spike tube set packaging, catalog number 0250070640, after an increase in complaints of leaking from the handpiece during use. The recall covers 2,739 units, and the notice reports no injuries. FDA classifies it as Class II.

From the FDA notice · Read the official notice ↗ · All Stryker recalls

What to do

  1. Set aside and stop using affected units from the listed batches.
  2. Check for GTIN 07613327061475 and batch numbers 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, and 25161FG2.
  3. Contact Stryker for next steps. The notice does not specify a remedy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
2,739 of units
Illnesses reported
None reported
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Classification
Class II
Recall number
Z-2864-2026

In the FDA's words

Description
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom. Affected quantity: 2,739 of units
Hazard
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

3 products in this recall

Stryker AHTO tube sets recalled for handpiece leaking

Stryker is recalling three tube set products: the AHTO Tube Set, the AHTO Dual Spike Tube Set and the Single Spike Tube Set. The FDA reports an increase in complaints describing leaking from the handpiece during use. The products were distributed in the US and in 17 other countries, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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