The Recall Desk
HighFDA (Devices)·Z-2422-2019·Announced 2019-09-04

Stryker Endotrac EPF/EGR Triangle Blade Recall for Compromised Sterile Seal

Stryker GmbH is recalling 21 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, posing a risk of contamination.

What this means for you

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 potential breach of sterile integrity for a surgical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker GmbH is recalling 21 units of the Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1. The recall is limited to Lot Number 01411, which was distributed nationwide in the United States. The EPF system is designed for the minimally invasive surgical treatment of chronic plantar fasciitis, while the EGR system is designed for the treatment of gastrocnemius equinus.

The recall was initiated because the seal integrity of the sterile bag containing the kits may be compromised. A compromised sterile seal can allow contamination of the surgical instruments, which poses a risk of infection or other adverse health consequences if the devices are used in a surgical procedure.

Healthcare facilities and consumers who have purchased or received these specific devices should stop using them immediately. Users should contact Stryker GmbH for instructions on how to return the affected units for replacement or refund. Do not use the devices if the sterile packaging appears damaged or if the seal is not intact.

The recalled product

Product
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-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
Category
Medical Device — Surgical Instruments
Hazard
Affected units
21

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 01411

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 →

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