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Moderate riskFDA DeviceClass II

Stryker AHTO tube set recalled for handpiece leakage

Stryker is recalling AHTO tube set packaging, catalog number 0250070600, with 46,212 units affected. The company received an increased number of complaints consistently describing leaking from the handpiece during use. The FDA has classified the recall as Class II, and no injuries have been reported.

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

What to do

  1. Stop using and set aside affected lots, identified by GTIN 07613327061499 and the batch numbers listed in the notice.
  2. Check batch numbers on the packaging against the list in the notice, which includes batches such as 24262FG2 and 25163FG2.
  3. The notice does not specify a remedy; contact Stryker for instructions on returns or replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
46,212 units
Illnesses reported
None reported
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Classification
Class II
Recall number
Z-2862-2026

In the FDA's words

Description
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. GTIN 07613327061499, Batch Numbers: 24262FG2, 24263FG2, 24264FG2, 24266FG2, 24267FG2, 24268FG2, 24269FG2, 24283FG2, 24284FG2, 24286FG2, 24287FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24293FG2, 24294FG2, 24295FG2, 24296FG2, 24298FG2, 24299FG2, 24302FG2, 24303FG2, 24304FG2, 24305FG2, 24306FG2, 24309FG2, 24311FG2, 24312FG2, 24316FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24321FG2, 24322FG2, 24323FG2, 24324FG2, 24325FG2, 24326FG2, 24337FG2, 24339FG2, 24346FG2, 24347FG2, 24348FG2, 24349FG2, 24350FG2, 24351FG2, 24352FG2, 24353FG2, 24354FG2, 24355FG2, 24356FG2, 24358FG2, 24361FG2, 25007FG2, 25008FG2, 25009FG2, 25010FG2, 25013FG2, 25014FG2, 25017FG2, 25020FG2, 25027FG2, 25028FG2, 25029FG2, 25035FG2, 25036FG2, 25037FG2, 25038FG2, 25041FG2, 25043FG2, 25044FG2, 25045FG2, 25048FG2, 25052FG2, 25055FG2, 25056FG2, 25057FG2, 25058FG2, 25059FG2, 25062FG2, 25063FG2, 25064FG2, 25065FG2, 25069FG2, 25070FG2, 25071FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25084FG2, 25085FG2, 25086FG2, 25087FG2, 25092FG2, 25093FG2, 25094FG2, 25097FG2, 25098FG2, 25099FG2, 25100FG2, 25101FG2, 25107FG2, 25112FG2, 25113FG2, 25114FG2, 25115FG2, 25118FG2, 25119FG2, 25120FG2, 25121FG2, 25122FG2, 25125FG2, 25126FG2, 25134FG2, 25135FG2, 25137FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25144FG2, 25148FG2, 25155FG2, 25160FG2, 25161FG2, 25162FG2, 25163FG2. 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: 46,212 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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