CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
Bipolar Forceps recalled by Stingray Surgical Products
Stingray Surgical Products is recalling Bipolar Forceps, distributed nationwide in the US. The recall was initiated on 23 May 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2011-2012
- FDA event ID
- 62024
- Recalling firm
- Stingray Surgical Products, Boca Raton, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2012
- FDA classified
- 13 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 May 2012 | Recall initiated by company | |
| 13 Jul 2012 | Classified by FDA | +51 days |
| 25 Jul 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide)
Questions about this recall
Is Bipolar Forceps recalled?
Yes. Stingray Surgical Products recalled Bipolar Forceps on 23 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2011-2012.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - USA (nationwide)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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