Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal
Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook 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, and the source text describes a potential defect (compromised seal) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker GmbH is recalling 110 units of the Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1. The recall involves Lot Number 01402, 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 EPF/EGR system is a minimally invasive surgical technique designed for the treatment of chronic plantar fasciitis (fasciosis) and gastrocnemius equinus. Healthcare providers and patients who have used or possess this specific lot of the hook blade should contact Stryker GmbH for further instructions on how to proceed.
The recalled product
- Product
- Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-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
- 110
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 01402
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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