Stryker Endoscopy PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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 manipulating fun Recall
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, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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 manipulating fun
Brand
Stryker Endoscopy
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
0200136B 0343780C 0441296C 0443152C 0540019C 0543638D 6112014 7312014 0845029D 0847459D 0847460D 0848127D 0940087D 0941072D 0943442D 0943690D 0944823D 1040626D 1040928D 1041984D 1043027D 1044518D 1045056D 1046104D 1046956D 1140857D 1141971D 1142616D 1143647D 1144959D 1145342D 1145878 1145878D 1146673D 1241510D 1242259D 1243096D 1243551 1243551D 1244182 1244645 1245796 1245797 1245797D 1245978 1245978H 1246407 1340934 1340934H 1341256 1341256H 1344090 1440292 1441860 1442306 9801674S
Stryker Endoscopy is recalling PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 Laparoscopic Manual Instruments are intended 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