Stryker single spike tube sets recalled for handpiece leakage
Stryker is recalling certain single spike tube sets (catalog 0250070530) after an increase in complaints describing leaking from the handpiece during use. The notice reports no injuries. The sets were distributed in the US and 18 other countries.
From the FDA notice · Read the official notice ↗ · All Stryker recalls
What to do
- Stop using affected tube sets and set aside any lots listed in the notice.
- Check the GTIN 07613327061352 and batch numbers on the packaging, which run from 24260FG2 to 25274FG2 and are listed in the notice.
- The notice doesn't say how to get a return or replacement; contact Stryker for instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 11,857 Units
- Illnesses reported
- None reported
- Manufactured in
- 5900 Optical Ct, San Jose, CA, United States
- Classification
- Class II
- Recall number
- Z-2865-2026
In the FDA's words
- Description
- STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. GTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2. 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: 11,857 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.
- STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600Z-2862-2026 · 46,212 units
- STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640Z-2864-2026 · 2,739 of units
- STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 (this page)Z-2865-2026 · 11,857 Units