The Recall Desk
ModerateFDA (Devices)·Z-1539-2018·Announced 2018-05-09

Beaver-Visitec Recalls Osher Thermodot Markers Due to Incorrect Tip

Beaver-Visitec is recalling 110 Osher Thermodot Markers because they were manufactured with a needle tip instead of the proper flat tip.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a defect without reported harm.

Plain-English summary

Beaver-Visitec International Inc. is recalling 110 units of the WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED (Part number 221270). The recall is due to a manufacturing error where the markers were produced with a needle tip instead of the proper flat tip.

The affected products are distributed to the states of Ohio, New York, Florida, Minnesota, and Kansas. The specific lot numbers involved are 6000292 (exp. 7/25/20) and 6000540 (exp. 08/30/20), with UDI 30886158014899. These devices are designed to create an ink-free, fine dot on the eye to serve as a precise reference point for various procedures.

Healthcare providers and consumers should stop using the affected devices immediately and contact Beaver-Visitec International Inc. for instructions on return or replacement.

The recalled product

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.
Affected units
110

Distribution

Distributed in 5 states:

Same manufacturer · Beaver-Visitec International Inc.

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