Z-2011-2012Class II

Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01...

Name: Z-2011-2012 Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01...
Creator: Stingray Surgical Products, LLC
Published: 2012-05-23
License: https://open.fda.gov/license/

Stingray Surgical Products / initiated 2012-05-23 / Terminated / root cause: packaging

FDA source

Stingray Surgical Products, LLC began a recall of 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... on 2012-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2011-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-23
Posted: 2012-07-13
Terminated: 2014-08-06
Recalling firm: Stingray Surgical Products
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.
Quantity in commerce: 6326
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2011-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2011-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-13

Product code GEI

K083162Class IIStingray Electrosurgical ForcepsStingray Surgical Products, Inc. / cleared 2009-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)