Stryker Recalls Endotrac ECTR Triangle Blades Due to Seal Integrity
Stryker GmbH is recalling 94 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.
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. The hazard involves a potential compromise in sterile packaging, which is a significant quality issue but does not involve reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker GmbH is recalling 94 units of the Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1. The recall is limited to Lot Number 01408, which was 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.
The Endotrac ECTR Triangle Blade is part of the EPF system, which is designed for the treatment of plantar fasciosis, a minimally invasive surgical technique for chronic plantar fasciitis. The EGR system is also designed for the treatment of gastrocnemius equinus. Healthcare providers and patients should stop using the affected units and contact Stryker GmbH for further instructions.
The recalled product
- Product
- Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-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…
- Manufacturer
- Stryker GmbH
- Hazard
- Affected units
- 94
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 Number 01408
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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