Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal
Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle 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 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 is a potential loss of sterility due to compromised packaging seals, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Stryker GmbH is recalling 1,533 units of the Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1. The affected lots are 01398, 01465, and 01481. 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. This defect could potentially affect the sterility of the surgical instruments.
The Endotrac EPF system is designed for the treatment of plantar fasciosis, a minimally invasive surgical technique for chronic plantar fasciitis. The EGR system is designed for the treatment of gastrocnemius equinus. Healthcare providers and patients should stop using the affected products and contact Stryker GmbH for further instructions.
The recalled product
- Product
- Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 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
- 1,533
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 01398
- 01465
- 01481
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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