FDA Medical Device Recalls (openFDA)
MicroSurgical Technology Inc: MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
- Recall number
- Z-0411-2026
- Recalling firm
- MicroSurgical Technology Inc
- Product
- MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
- Status
- Open, Classified
- Initiated
- 2025-08-20
- Posted
- 2025-10-29
- Terminated
- not on file
- Reason
- An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
- Root cause
- Material/Component Contamination
- Action
- On 8/20/2025, a recall notice was sent to a surgery center that was asked to return the affected devices and provide information on affected device disposition. The customer was also asked, if they further distributed affected devices, to notify their customers of the recall For additional information, contact the firm at MSTcomplaints@microsurgical.com
- Quantity
- 8
- Distribution
- US Nationwide distribution in the state of GA.
- Lot, serial or model codes
- UDI:00844685014316. Lots: 207552 and 208238
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 3019924
- Firm city
- Redmond
- Firm state
- WA
- 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