Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, ALLIS SINGLE ROW TEETH, P/N 0250080591 Laparoscopic Manual Instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The recall is due to a documentation error in the Instructions for Use (IFU 1000-401-070 Revision G or prior), which do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, 5MM INSERT, ALLIS SINGLE ROW TEETH, P/N 0250080591 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) port
- 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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