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FDA recall, , Moderate risk

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker tube sets can leak from the handpiece during use.

What happened

Stryker Corporation, of San Jose, California, recalled certain tube set packaging products because of an increased amount in reported complaints consistently describing leaking from the handpiece during use. The recall began on June 8, 2026, and was added to the FDA's Enforcement Report on August 3, 2026.

The products were distributed nationwide and worldwide, including to Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match the UDI-DI and lot code listed under your product.

Incomplete list: 133 of 295 lot codes shown.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Stryker Ahto Dual Spike Tube Set Packaging, Catalog Number 0250070640

    UDI-DI
    • 07613327061475
    Lot code
    • 24284FG2
    • 24289FG2
    • 24313FG2
    • 24322FG2
    • 24338FG2
    • 24344FG2
    • 24351FG2
    • 25009FG2
    • 25036FG2
    • 25062FG2
    • 25091FG2
    • 25129FG2
    • 25161FG2
  2. Stryker Ahto Tube Set Packaging, Catalog Number 0250070600

    UDI-DI
    • 07613327061499
    Lot code
    • 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
  3. Stryker PKG., Single Spike Tube Set, Catalog Number 0250070530

    UDI-DI
    • 07613327061352
    Lot code
    • 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
  4. Stryker Ahto Tube Set with Tip Packaging, Catalog Number 0250070620

    UDI-DI
    • 07613327061659
    Lot code
    • 24263FG2
    • 24264FG2
    • 24265FG2
    • 24267FG2
    • 24269FG2
    • 24270FG2
    • 24271FG2
    • 24288FG2
    • 24289FG2
    • 24290FG2
    • 24291FG2
    • 24292FG2
    • 24296FG2
    • 24297FG2
    • 24298FG2
    • 24304FG2
    • 24306FG2
    • 24313FG2
    • 24317FG2
    • 24318FG2
    • 24319FG2
    • 24320FG2
    • 24327FG2
    • 24340FG2
    • 24341FG2
    • 24342FG2
    • 24343FG2
    • 24344FG2
    • 24345FG2
    • 24347FG2
    • 24348FG2
    • 24356FG2
    • 24357FG2
    • 24358FG2
    • 24361FG2
    • 25007FG2
    • 25010FG2
    • 25011FG2
    • 25015FG2
    • 25016FG2
  5. Stryker PKG., Strykeflow Suction/Irrigator PS, Catalog Number 0250070540

    UDI-DI
    • 0761332706146
    Lot code
    • 24297FG2
    • 24306FG2
    • 24344FG2
    • 25007FG2
    • 25065FG2
    • 25091FG2
    • 25168FG2

Recall details

Company began the recall
Sold in

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.

Company
Stryker CorporationSan Jose, California
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99340
Recall numbers
Z-2862-2026 to Z-2866-2026

All recalls from Stryker Corporation

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)