Z-0970-2024Class II

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Name: Z-0970-2024 Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Creator: Vortex Surgical Inc.
Published: 2023-12-18
License: https://open.fda.gov/license/

Vortex Surgical, Inc. / initiated 2023-12-18 / Terminated / root cause: design

FDA source

Vortex Surgical Inc. began a recall of Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 on 2023-12-18. FDA classified it as Class II and gives the reason as "Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0970-2024
Classification: Class II
Status: Terminated
Initiated: 2023-12-18
Posted: 2024-02-01
Terminated: 2024-04-04
Recalling firm: Vortex Surgical, Inc.
Product: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Product code: HNR Forceps, Ophthalmic
Reason for recall: Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/18/2023 via email. The notice explained the problem with the device, risk to health associated with its use, and requested the return of all devices.
Quantity in commerce: 800 devices
Distribution: Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Product codes and lots: UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0970-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0970-2024	Class II	Terminated	Voluntary: Firm initiated	2024-02-07	2024-02-01

Product code HNR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)