The Recall Desk
HighFDA (Devices)·Z-1848-2019·Announced 2019-06-26

Stryker Recalls Endotrac Hook/Triangle Blade Kits Due to Seal Integrity

Stryker GmbH is recalling 447 Endotrac ECTR Hook/Triangle Blade Kits because the sterile bag seal may be compromised, potentially affecting sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker GmbH is recalling 447 units of the Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1, Lot # 01410. The recall was initiated because the seal integrity of the sterile bag containing the kits may be compromised. This defect could potentially affect the sterility of the medical devices.

The affected products were distributed nationwide in the United States. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific dates or additional distribution details are provided in the source text.

Healthcare providers and consumers should stop using the affected kits and contact Stryker GmbH for further instructions or a replacement.

The recalled product

Product
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instruments
Hazard
Affected units
447

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)

  • Lot # 01410

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Stryker GmbH 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 2 products in this recall →

Related recalls

Same manufacturer · Stryker GmbH

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Same hazard · sterility compromise

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