Beaver Accu-Temp High Temperature Cautery — Class II medical device recall Z-3045-2018
Terminated recall by Beaver Visitec, reported 2018-09-19, distributed nationwide. A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk
| Recall number | Z-3045-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec, Waltham, MA, United States |
| Recall initiated | 2018-07-19 |
| Classified | 2018-09-13 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ES, FR, GB, NL |
| Quantity | 800 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 30886158010297 |
| Lot numbers | 6002809 |
| Model numbers | 8445000 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3045-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.