Stryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity
Stryker GmbH is recalling 476 Endotrac ECTR Push Blades because the sterile bag seal integrity 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 3/5 (High).
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 involves a medical device where the sterile barrier may be compromised, posing a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling 476 units of the Endotrac ECTR Push Blade, Catalog Number 2053-1, Lot Number 01400. 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.
The affected units were distributed nationwide in the United States. A compromised sterile bag seal may allow contamination, posing a risk of infection if the device is used in a surgical procedure. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients should stop using the affected Endotrac ECTR Push Blades immediately. Stryker GmbH is the recalling firm responsible for managing the recall. Users should contact the manufacturer or their medical device supplier for instructions on returning or replacing the product.
The recalled product
- Product
- Endotrac ECTR Push Blade, Catalog Number 2053-1 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
- Affected units
- 476
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 01400
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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