Stryker Single Spike Tube Set Recall Issued
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Stryker Corporation is recalling 11,857 units of its Single Spike Tube Set due to reports of leaking from the handpiece during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Stryker Corporation initiated a recall after an increased number of complaints described leaking from the handpiece during use.
Which Products Are Affected
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530. GTIN 07613327061352. Affected 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. A total of 11,857 units are affected. Distribution includes 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, and the United Kingdom. Recall number Z-2865-2026. Class II recall.
What You Should Do
The recall was initiated voluntarily by the firm via letter. Consumers with affected products should follow instructions provided by Stryker Corporation.
Why This Matters
This Class II recall addresses a device defect that could lead to temporary or reversible adverse health consequences.
Source
FDA recall Z-2865-2026, report date 20260812.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,317 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.