The Recall Desk
HighFDA (Devices)·Z-2036-2020·Announced 2020-05-27

Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood 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 involves a medical device used in surgery where failure to occlude vessels poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Applied Medical Resources Corp is recalling 2,240 units of the Stealth Spring Clip 6mm latis (3/4 Force). The recall is due to a failure of the cardiovascular clips to provide sufficient occlusion of the vessel. The affected product is identified by Lot # 1357103, with a manufacture date of June 4, 2019, and an expiration date of June 2, 2024.

The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The recall covers worldwide distribution, including nationwide distribution in the United States and specific countries in Europe, Asia, and the Americas.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting a representative.

The recalled product

Product
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Affected units
2,240

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 # 1357103
  • Manufacture Date June 4
  • 2019
  • Expiration Date June 2
  • 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 →