Class II — Beaver Visitec
| Recalling firm | Beaver-Visitec International, Inc. |
|---|---|
| Registered facility | Beaver-Visitec International, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient. |
| Product | Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery. |
| Quantity | 800 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom. |
| Initiated | 2018-07-19 |
| Classified | 2018-09-13 |
| Terminated | 2019-05-23 |
| Recall number | Z-3045-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beaver Visitec (Z-3045-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80846/
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