The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0604-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error

Stryker Endoscopy is recalling 180,573 units of 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 documentation/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 laparoscopic manual instruments, specifically the PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA (P/N 0250080157). The recall covers instruments intended for cutting, holding, grasping, and manipulating tissue during laparoscopic surgery. The affected products were distributed nationwide in the United States and internationally to numerous countries, including Canada, Mexico, the United Kingdom, Germany, and Japan.

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 error means the provided instructions do not accurately reflect the sterilization capabilities of the devices for these specific cycles.

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 may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; 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)…
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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