Class II — Stingray Surgical Products, LLC
| Recalling firm | Stingray Surgical Products |
|---|---|
| Registered facility | STINGRAY SURGICAL PRODUCTS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 6326 |
| Distribution | Worldwide Distribution - USA (nationwide) |
| Initiated | 2012-05-23 |
| Classified | 2012-07-13 |
| Terminated | 2014-08-06 |
| Recall number | Z-2011-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stingray Surgical Products, LLC (Z-2011-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62024/
Alerts for Stingray Surgical Products
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.