Stryker Endotrac Hook/Triangle Blade Kit Recall Due to Seal Integrity
Stryker GmbH is recalling 1,600 Endotrac EPF/EGR Hook/Triangle Blade Kits because the sterile bag seal integrity may be compromised.
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 source text describes a potential defect (compromised seal) without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker GmbH is recalling 1,600 units of the Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1. The affected products are identified by Lot #s 01404 and 01478. These kits were distributed nationwide in the United States.
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 device.
Healthcare providers and consumers should check their inventory for the specific catalogue number and lot numbers listed above. If the product is found, it should be removed from use and returned to Stryker GmbH in accordance with their recall instructions.
The recalled product
- Product
- Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
- Manufacturer
- Stryker GmbH
- Hazard
- Affected units
- 1,600
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 (2)
- Lot #s 01404
- 01478
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.
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