Stryker Endotrac ECTR Triangle Blade Recalled Due to Compromised Sterile Bag Seal
Stryker GmbH is recalling 53 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential risk without confirmed harm.
Plain-English summary
Stryker GmbH is recalling 53 units of the Endotrac ECTR Triangle Blade, Catalog Number 2054-1, Lot Number 01407. The product is a medical device used in the EPF system for the treatment of plantar fasciosis and the EGR system for gastrocnemius equinus.
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 device.
The affected units were distributed nationwide in the United States. Healthcare providers and patients should stop using the affected lots and contact Stryker GmbH for further instructions.
The recalled product
- Product
- Endotrac ECTR Triangle Blade, Catalog Number 2054-1 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
- 53
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 01407
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.
See all 13 products in this recall →Related recalls
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