Stingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions
Stingray Surgical Products is recalling bipolar forceps because the Instructions For Use were altered without FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect sterilization instructions, which is a significant labeling and compliance issue, but the source text does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Stingray Surgical Products, LLC, of Boca Raton, Florida, initiated a recall of Bipolar Forceps on May 23, 2012. The affected models include S02-XXX, S03-XXX, P02-XXX, and P03-XXX. These instruments are designed to grasp, manipulate, and coagulate selected tissue for use in general surgical procedures powered by a high-frequency generator.
The recall was initiated because the "Instructions For Use" (IFU) for these devices were not cleared by the FDA. Specifically, the sterilization instructions contained in the IFU (documents QF7.5.1A.R01 through QF7.5.1A.R06) were altered without receiving the necessary clearance from the agency. The source text indicates that 6,326 units were distributed worldwide, including nationwide distribution in the USA.
Healthcare facilities and users should stop using the affected bipolar forceps and contact the recalling firm for further instructions regarding the replacement or correction of the instructions.
The recalled product
- 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…
- Manufacturer
- Stingray Surgical Products, LLC
- Affected units
- 6,326
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Bipolar Forceps model number: S02-XXX
- S03-XXX
- P02-XXX
Distribution
Distributed nationwide across the United States.
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