Stryker Endotrac Push Blade Recalled for Compromised Sterile Bag Seal
Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker GmbH is recalling 251 units of the Endotrac EPF/EGR Push Blade, Catalog Number 3053-1. The affected lots are 01399, 01464, and 01477. These products were distributed nationwide in the United States.
The recall is being issued because the seal integrity of the sterile bag containing the kits may be compromised. The Endotrac EPF/EGR system is a minimally invasive surgical technique designed for the treatment of chronic plantar fasciitis (fasciosis) and gastrocnemius equinus.
Healthcare providers and facilities that have received these specific lots should stop using the affected push blades and contact Stryker GmbH for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of…
- Manufacturer
- Stryker GmbH
- Hazard
- Affected units
- 251
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 (3)
- Lot Numbers 01399
- 01464
- 01477
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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