Stryker Endoscopy Recalls Endoloop Applicator Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Endoloop Applicator units because the 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 the source text identifies the issue as a documentation error in the Instructions for Use rather than a reported injury or structural defect, aligning with the Moderate severity criteria for minor labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, ENDOLOOP APPLICATOR (P/N 0250080701). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgical procedures. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is being conducted 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. This documentation issue may affect the proper sterilization of the devices.
Healthcare facilities and distributors should stop using the affected units and contact Stryker Endoscopy for further instructions. The recall number is Z-0729-2015.
The recalled product
- Product
- PKG, ENDOLOOP APPLICATOR, P/N 0250080701 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…
- 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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