Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a documentation issue regarding sterilization parameters rather than a reported injury or high-risk pathogen, aligning with the Moderate severity criteria for minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments and accessories. The affected products include the PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, with part number 0250282105. These instruments are intended for cutting, holding, grasping, and manipulating tissue during laparoscopic surgery.
The recall was initiated because 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. The agency has classified this as a Class II recall.
The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, the United Kingdom, Germany, and Japan. No specific dates or lot numbers are provided in the source text beyond the part number and IFU revision.
The recalled product
- Product
- PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 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 fre
- 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)
- 844265 1041466 1142561 1243266
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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