The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0764-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

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: This is a Class II recall involving a labeling error regarding sterilization methods. The rubric classifies minor labeling errors and voluntary precautionary recalls as Moderate severity, particularly when no injuries or illnesses are reported.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments, specifically the PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006. 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, Germany, and Japan.

The recall was initiated because the parameters provided in the 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 protocols for the device.

Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 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…
Manufacturer
Stryker Endoscopy
Category
Medical Device — Surgical Instruments
Hazard
Affected units
180,573

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 641423 842870 847465 847466 1045580 1140528

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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