Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic needle nose forceps because the instructions for use do not support specific sterilization methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a documentation error in the Instructions for Use regarding sterilization parameters. There are no reported injuries, illnesses, or deaths, and the hazard is theoretical, fitting the criteria for a Low severity score (documentation issues).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM (P/N 0250282005). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is due to a documentation issue where the parameters provided in the 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.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, Germany, and Japan. The specific lot codes associated with this recall are 440605, 845863, 845884, 846789, 847018, and 1246166.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall and replacement or repair options.
The recalled product
- Product
- PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM, P/N 0250282005 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) p
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
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 (1)
- 440605 845863 845884 846789 847018 1246166
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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