Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a documentation issue regarding sterilization instructions. Per the rubric, minor labeling or documentation issues without reported illness are typically scored as Moderate (2).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments and accessories. 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 products are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including nationwide in the United States and internationally to numerous countries. The specific product identified is the PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110.
This recall is classified as Class II by the FDA. No illnesses or injuries are reported in the source text. The hazard is related to the lack of documented support for specific sterilization cycles in the user manual, which may affect the proper use and safety verification of the devices.
The recalled product
- Product
- PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 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)…
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
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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