The Recall Desk
ModerateFDA (Devices)·Z-0682-2015·Announced 2014-12-24

Stryker Endoscopy Recalls 33cm Dorsey Grasper Forceps Due to Sterilization Labeling

Stryker Endoscopy is recalling 180,573 units of 33cm Dorsey Grasper Forceps 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 and involves a documentation/labeling issue regarding sterilization parameters, which fits the 'Moderate' criteria for minor labeling errors or low-risk contamination without reported injuries.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of 33cm Dorsey Grasper Forceps (P/N 0250080319). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.

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. This documentation issue affects the ability to verify proper sterilization for these specific cycles.

Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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 all
Manufacturer
Stryker Endoscopy
Affected units
180,573

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 207 products in this recall →