CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report
Wet-field Osher Thermodot Marker Fine Tip, Curved recalled
Beaver-Visitec International is recalling Wet-field Osher Thermodot Marker Fine Tip, Curved, distributed in Florida, Kansas, Minnesota, New York. The recall was initiated on 26 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1539-2018
- FDA event ID
- 79908
- Recalling firm
- Beaver-Visitec International, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2018
- FDA classified
- 27 Apr 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Feb 2018 | Recall initiated by company | |
| 27 Apr 2018 | Classified by FDA | +60 days |
| 9 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Distributed to the states of OH, NY, FL, MN, and KS.
Questions about this recall
Is Wet-field Osher Thermodot Marker Fine Tip, Curved recalled?
Yes. Beaver-Visitec International recalled Wet-field Osher Thermodot Marker Fine Tip, Curved on 26 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1539-2018.
Why was it recalled?
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Which lots are affected?
Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899
Where was it sold?
Distributed to the states of OH, NY, FL, MN, and KS.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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