WET-FIELD OSHER THERMODOT MARKER — Class II medical device recall Z-1539-2018
Terminated recall by Beaver-Visitec International Inc., reported 2018-05-09, distributed in FL, KS, MN, NY, OH. Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip inste
| Recall number | Z-1539-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver-Visitec International Inc., Waltham, MA, United States |
| Recall initiated | 2018-02-26 |
| Classified | 2018-04-27 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-01-28 |
| Distributed | FL, KS, MN, NY, OH |
| Quantity | 110 products |
| UPC / GTIN / UDI-DI | 30886158014899 |
| Lot numbers | 6000292, 6000540 |
| Model numbers | 221270 |
| Expiration dates | 2020-07-25, 2020-08-30 |
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 for recall
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1539-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.