FDA (Devices) recall action 99340
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.