The Recall Desk
ModerateFDA (Devices)·Z-2415-2019·Announced 2019-09-04

Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns

Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

What this means for you

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 1,959 units of the Endotrac ECTR Hook Blade, Catalog Number 2055-1. The affected products are identified by Lot Numbers 01409 and 01476. These devices were distributed nationwide in the United States.

The recall was initiated because the seal integrity of the sterile bag containing the kits may be compromised. The Endotrac ECTR Hook Blade is part of a system designed for the minimally invasive surgical treatment of chronic plantar fasciitis and gastrocnemius equinus.

Healthcare providers and facilities should stop using the affected lots and contact Stryker GmbH for further instructions on returns or replacements.

The recalled product

Product
Endotrac ECTR Hook Blade, Catalog Number 2055-1 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 gastrocnemiu
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,959

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 (2)

  • Lot Numbers 01409
  • 01476

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

Same manufacturer · Stryker GmbH

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Same hazard · sterility compromise

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