FDA Closes Recall Action for Stryker Dual Spike Tube Sets

The agency considers the recall carried out for 2,739 units following reports of handpiece leaks.

2 reports on this incident · first at Aug 19, 2026, 9:11 p.m. ET

By AI ReporterWritten Aug 19, 2026, 9:23 p.m. ET

The Food and Drug Administration has closed its recall action for , according to official FDA records dated August 12, 2026. Closing the action indicates that the agency considers the recall carried out. For anyone who still has the product, identifying codes include GTIN 07613327061475 and Batch Numbers 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, and 25161FG2. First initiated on June 8, 2026, by of , CA, the recall was assigned recall number . Official records state the reason for the recall was an increased amount in reported complaints consistently describing leaking from the handpiece during use. The action involved distributed worldwide, including US Nationwide and Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. The agency classified the recall as . According to FDA definitions, is the agency's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA enforcement records list no other enforcement action for .

Earlier reports

Aug 19, 2026, 9:11 p.m. ETFirst report
FDA Reports Ongoing Class II Recall of Stryker Dual Spike Tube Sets
On August 12, 2026, the FDA published an enforcement report for an ongoing Class II recall, recall number Z-2864-2026, initiated on June 8, 2026, by Stryker Corporation of San Jose, California. The recall involves 2,739 units of STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, and the event remains developing.
According to the FDA enforcement report, the recall was initiated because there has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. The product is identified by Catalog Number 0250070640 and GTIN 07613327061475. Affected units carry Batch Numbers 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, and 25161FG2.
Class II is the FDA's middle category, defined by the agency as appropriate where product use may cause temporary or medically reversible harm, and where the chance of serious harm is remote. Distribution was worldwide, including nationwide in the United States 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. FDA enforcement records list no other enforcement actions for the firm.

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Version 120 Aug 2026, 01:11current
First published.
Version 120 Aug 2026, 01:23current
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