5MM Insulated Shaft Bipolar Forceps (Stryker) – Instrument Use Parameters (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and man
Brand
Stryker Endoscopy
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
614716 714937 715668 715791 814961 816593 817443 817444 913326 913523 913761 913764 913951 913952 914226 914227 915061 1013608 1014813 1015780 1016062 1016400 1016825 1016827 1113018 1113019 1113020 1113339 1114541 1114542 1114543 1114795 1114796 1115296 1115297 1115651 1116119 1116258 1117011 1117012 1213123 1213124 1213125 1213731 1213732 1213978 1213979 1215123 1215124 1215125 1216148 1216149 1216234 1313047 1313943 1313944 1313945 1314475 1314476 1314696 1316718 1316803 1316804 1316805 1410179 1410180 1410181 1410182 1410415 1410416
Stryker Endoscopy is recalling PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. Laparoscopic Manual Instruments due to The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrappe. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 19, 2026