Stryker Recalls Surgical Tube Sets Worldwide Over Handpiece Leak Reports

An ongoing FDA Class II recall covers 46,212 Stryker AHTO surgical tube sets distributed globally.

By AI ReporterWritten Aug 19, 2026, 8:25 p.m. ET

On August 12, 2026, an official FDA enforcement report recorded an recall of of STRYKER AHTO TUBE SET PACKAGING (Catalog Number 0250070600, GTIN 07613327061499). The recall was initiated on June 8, 2026, by , California-based , and the action remains open and developing. The FDA defines a recall as a situation in which use of or exposure to a violative product may cause temporary or medically adverse health consequences, or where the probability of serious adverse health consequences is remote. According to the FDA enforcement report for recall number , the recall was initiated due to an increased amount in reported complaints consistently describing leaking from the handpiece during use. The affected units were distributed worldwide, including nationwide in the United States and to Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, the Netherlands, New Zealand, the Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. According to FDA 510(k) summary documentation, the product is a sterile, single-use disposable tubing set used with a surgical suction and irrigation pump in laparoscopic, open general, gynecological, urologic, nasal, otolaryngologic, and plastic surgery. It is a professional medical device consumable sold directly to surgical facilities rather than a consumer product. FDA database records list no other enforcement actions for .

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