Formula Shaver Handpiece — Class II medical device recall Z-1866-2012
Terminated recall by Stryker Endoscopy, reported 2012-07-04, distributed nationwide. Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to
| Recall number | Z-1866-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2012-05-21 |
| Classified | 2012-06-25 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2012-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, GB |
| Quantity | 34 devices |
| Serial numbers | 12B037204, 12B037214, 12B037224, 12B037234, 12B040594, 12B040604, 12B040614, 12B040624, 12B040634, 12B040644, 12B040654, 12B040664, 12B040684, 12B041374, 12B046934, 12B046964, 12B046974, 12B046994, 12B047004, 12B047014, 12B047024, 12B047034, 12B047054, 12B047064, 12B047074 and 9 more |
Product
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
Reason for recall
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1866-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.