Stryker Endoscopy PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 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 functions. 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, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 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 functions.
Brand
Stryker Endoscopy
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
42167 42169 42172 43238 43239 81309 142647 143476 143477 245841 342652 344115 345130 0442468C 0445112D 0541360D 0541361D 0641114D 0641115D 0644773D 0645377D 0647994D 06CON06071 06CON06126 07022013E 0740507D 0740834D 0741766D 0742442D 0742740D 0744063D 0744684D 0745499D 0746059D 0746497D 0747592D 0840357D 0840678D 0841358D 0842085D 0842130D 0845885D 0846565D 0847512D 9292011 0940124D 0940126D 0940127D 0941052D 0941067D 0942146D 0942277D 0942850D 0943496D 0944142D 0945209D 0945467D 0945715D 1040120D 1040385D 1040583D 1040805D 1041471D 1041627D 1041982D 1042493D 1043025D 1043102D 1043511D 1043778D 1044521D 1044523D 1046109D 1046189D 1046193D 1141605D 1141791D 1142149D 1142927D 1143476D 1143648D 1143972D 1144238D 1144345D 1144346D 1144395D 1144642D 1144656D 1144961D 1145073D 1145344D 1145810D 1145941D 1146537D 1146660D 1146661D 1240125D 1240950D 1241422D 1241512D 1242235D 1242642D 1242713D 1242929 1242929D 1243097 1243097D 1243552 1244644 1340202 1340554 1340554H 1341605 1341605H 1341606 1341606H 1341608 1341608H 1343303 1343303H 1343724 1343724H 1345516 1345516H 1346542 1346542H 1346543 1440947 1440947H 1440955 1440955H
Stryker Endoscopy is recalling PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for cu 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 12, 2026