Wet-Field Osher Thermodot Marker, 25ga Fine Tip, Curved recallZ-1539-2018 · Beaver-Visitec International Inc. · initiated Feb 26, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beaver-Visitec International Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
FDA root cause category: Process control
What the company is doing
On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.
Recall details
- Recall number
- Z-1539-2018
- Status
- Terminated
- Initiated by the company
- Feb 26, 2018
- Recalling firm
- Beaver-Visitec International Inc.
- Quantity
- 110 total products
- Product code
- GEI
- FDA submissions
- K911160
- Distribution
- Distributed to the states of OH, NY, FL, MN, and KS.
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Wet-Field® 221270Beaver-Visitec International, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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