Z-0521-2025Class II

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads...

Name: Z-0521-2025 Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads...
Creator: MicroSurgical Technology Inc
Published: 2024-09-17
License: https://open.fda.gov/license/

MicroSurgical Technology Inc / initiated 2024-09-17 / Open, Classified / root cause: manufacturing process

FDA source

MicroSurgical Technology Inc began a recall of Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number... on 2024-09-17. FDA classified it as Class II and gives the reason as "Due to pin coming off of handles". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0521-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-17
Posted: 2024-11-22
Recalling firm: MicroSurgical Technology Inc
Product: Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
Product code: HNF Scissors, Ophthalmic
Reason for recall: Due to pin coming off of handles.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/24/2024, the firm sent via express mail a customer letter informing customers that there is a potential issue pertaining to the pins on the handle of the DFH-1028, Handle Assembly Lot Number 160458. The locking pins that actuate the head may be defective and could potentially dislodge without warning. As a precautionary measure, the firm is replacing the handle associated with the affected lot number 160458 at no cost to customers. Customers are being instructed to return the affected products using the supplied return shipping label. Firm's contact information if questions or further assistance is needed: David Wang Sr. VP of Ops QA/RA D: 206-402-1146 8415 154th Avenue NE | Redmond, WA 98052 www.microsurgical.com [email protected]
Quantity in commerce: 24
Distribution: U.S.: CT, GA, MN, MT and TX. O.U.S.: Netherlands 24 total devices = 6 devices distributed in the United States and 18 devices distributed in Germany.
Product codes and lots: Lot Code: Product Codes: HNF or HNR (Regulation Number 886.4350). Either code can apply as the Duet Handle Assembly can be used with MST Duet Ophthalmic Scissors or MST Duet Forceps. UDI: 00844685005536 Lot #: 160458. Lot number is a sequential number generated through the internal SAP. All finished goods can be effectively traced by the lot number as either the finished good part or the sub part used. Expected life: The number of handle reprocessing cycles is not limited as long as the post-cleaning and pre-use inspections determine that the product is still functional and shows no signs of damage or corrosion.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0521-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0521-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22

Product code HNF

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)