Z-2035-2020Class II

STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 -

Name: Z-2035-2020 STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 -
Creator: Applied Medical Resources Corp
Published: 2020-01-31
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2020-01-31 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during... on 2020-01-31. FDA classified it as Class II and gives the reason as "Failure of cardiovascular clips to provide sufficient occlusion of the vessel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2035-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-31
Posted: 2020-05-15
Terminated: 2022-04-20
Recalling firm: Applied Medical Resources Corp
Product: STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Product code: DSS Clip, Vascular
Reason for recall: Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: LOT # 1360356, Manufacture Date July 5, 2019; Expiration Date July 3, 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2034-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2035-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2036-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2037-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15

Product code DSS

K883909Class IISurgical Spring ClipsApplied Vascular Devices, Inc. / cleared 1988-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)