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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Beaver-Visitec International Inc.
- Hazard
- Affected units
- 110
Distribution
Related recalls
Same manufacturer · Beaver-Visitec International Inc.
See all →- ModerateLaser and endoscopy systems recalled over ferrites omitted from a USB cable
FDA (Devices) · 2026-01-07
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateBeaver-Visitec Recalls Hemostatic Eraser Bipolar Due to Incorrect Labeling
FDA (Devices) · 2018-05-16
- HighBVI Wet-Field Eraser surgical devices shipped with incorrect tip configuration
FDA (Devices) · 2022-06-29
- HighBeaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle
FDA (Devices) · 2014-06-04
- LowViscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow
FDA (Devices) · 2013-04-10
- HighGuider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
FDA (Devices) · 2023-10-11
- HighBeaver Accu-Temp High Temperature Cautery Recalled for Sterility Risk
FDA (Devices) · 2018-09-19