Class II U.S. Food and Drug Administration

Stryker Ahto Tube SET With TIP Packaging recall: There has been an increased amount in reported complaints consistently

Recall published 2 months ago

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2863-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Corporation
Product type
Medical devices
Units affected
41,052 units
Distribution
Nationwide
Made in
United States
Lot / code info
GTIN 07613327061659, Batch Numbers: 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, 25017FG2, 25020FG2, 25021FG2, 25022FG2, 25023FG2, 25024FG2, 25027FG2, 25028FG2, 25030FG2, 25037FG2, 25038FG2, 25041FG2, 25042FG2, 25043FG2, 25049FG2, 25050FG2, 25051FG2, 25055FG2, 25065FG2, 25066FG2, 25069FG2, 25070FG2, 25071FG2, 25072FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25083FG2, 25084FG2, 25085FG2, 25086FG2, 25090FG2, 25091FG2, 25092FG2, 25093FG2, 25097FG2, 25098FG2, 25098GF2, 25099FG2, 25100FG2, 25104FG2, 25105FG2, 25106FG2, 25111FG2, 25112FG2, 25127FG2, 25128FG2, 25129FG2, 25132FG2, 25133FG2, 25134FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25143FG2, 25147FG2, 25148FG2, 25149FG2, 25150FG2, 25151FG2, 25153FG2, 25154FG2, 25155FG2, 25156FG2, 25157FG2.
UPC codes
07613327061659

Products covered by this recall

STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07613327061659

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24263FG2
  • 24264FG2
  • 24265FG2
  • 24267FG2
  • 24269FG2
  • 24270FG2
  • 24271FG2

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Stryker Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Stryker Corporation — 5900 Optical Ct, San Jose, CA, 95138-1400

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Stryker Corporation medical devices recalled?

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07613327061659; lot code 24263FG2, 24264FG2, 24265FG2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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