FDA Device recall Z-1539-2018
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED by Beaver Visitec International, citing incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1539-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-26 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beaver Visitec International |
| Distribution | FL, KS, MN, NY, OH |
Product
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Reason
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Identifiers
| code_info | Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1539-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.