The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0733-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments 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 hazard is a documentation error regarding sterilization methods rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, ENDO GRASPER, 45CM, P/N 0250080726 Laparoscopic Manual Instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The recall is due to an 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 such as Canada, the United Kingdom, Germany, and Japan. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.

Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall and replacement of the documentation.

The recalled product

Product
PKG, 5MM INSERT, ENDO GRASPER, 45CM, P/N 0250080726 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…
Manufacturer
Stryker Endoscopy
Category
Medical Device — Surgical Instruments
Hazard
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 →

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