The Recall Desk
HighFDA (Devices)·Z-2037-2020·Announced 2020-05-27

Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure

Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

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 is classified as FDA Class II, and the hazard involves a surgical device failing to occlude vessels, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Applied Medical Resources Corp is recalling 750 units of the Stealth Spring Clip 6mm latis (1/4 Force), a non-sterile surgical device. The specific lot number is 1360163, with a manufacture date of July 3, 2019, and an expiration date of July 3, 2024.

The recall was initiated because the cardiovascular clips may fail to provide sufficient occlusion of the vessel. This device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

The affected units were distributed worldwide, including nationwide in the United States and in countries such as Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and the Netherlands. Healthcare facilities and distributors should stop using the affected clips and contact the manufacturer for further instructions.

The recalled product

Product
STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Surgical Instruments
Hazard
Affected units
750

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 (5)

  • LOT # 1360163
  • Manufacture Date July 3
  • 2019
  • Expiration Date July 3
  • 2024

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Applied Medical Resources Corp 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 4 products in this recall →

Related recalls

Same manufacturer · Applied Medical Resources Corp

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