Bipolar Forceps model number: S02-XXX — Class II medical device recall Z-2011-2012
Terminated recall by Stingray Surgical Products, LLC, reported 2012-07-25, distributed nationwide. On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructi
| Recall number | Z-2011-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stingray Surgical Products, LLC, Boca Raton, FL, United States |
| Recall initiated | 2012-05-23 |
| Classified | 2012-07-13 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2014-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 6,326 |
| Model numbers | P02-XXX, P03-XXX, S02-XXX, S03-XXX |
Product
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
Reason for recall
On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.
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-2011-2012. 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.