FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Recall number
- Z-2034-2020
- Recalling firm
- Applied Medical Resources Corp
- Product
- STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
- Status
- Terminated
- Initiated
- 2020-01-31
- Posted
- not on file
- Terminated
- 2022-04-20
- Reason
- Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
- Root cause
- Nonconforming Material/Component
- Action
- On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.
- Quantity
- 2240 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and Netherlands.
- Lot, serial or model codes
- LOT # 1359929, Manufacture Date June 28, 2019; Expiration Date June 26, 2024
- 510(k) numbers
- ["K883909"]
- PMA numbers
- not on file
- Product code
- DSS
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28