The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0627-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

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 involves a labeling error regarding sterilization methods, which fits the rubric criteria for minor labeling errors or low-risk contamination without reported injuries.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, SPRING HANDLE, P/N 0250080237 Laparoscopic Manual Instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America.

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 labeling discrepancy means the provided documentation does not accurately reflect the supported sterilization processes for these devices.

Healthcare facilities and distributors 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 could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product
PKG, SPRING HANDLE, P/N 0250080237. 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 them…
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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