CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

Pkg., Single Spike Tube Set recalled by Stryker

Stryker is recalling Stryker Pkg., Single Spike Tube Set, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 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.

Quantity recalled11,857 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2865-2026
FDA event ID: 99340
Recalling firm: Stryker, San Jose, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2026
FDA classified: 3 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

8 Jun 2026	Recall initiated by company
3 Aug 2026	Classified by FDA	+56 days
12 Aug 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Where it was distributed

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.

Nationwide

Questions about this recall

Is Pkg., Single Spike Tube Set recalled?

Yes. Stryker recalled Pkg., Single Spike Tube Set on 8 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2865-2026.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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