FDA Devices recall · Reported September 19, 2018
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.
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 …
Beaver Visitec recalled Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 84450… - a moderate-severity action.
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 84450… was recalled by Beaver Visitec in September 19, 2018. Reason: A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk…. Check the official notice for the remedy. Verify recall #Z-3045-2018 with the FDA Devices before acting.
The recall
Beaver Visitec issued this moderate-severity FDA Devices recall-A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk….
- Moderate
- severity level
- 800 units
- affected scope
- Class II
- classification
- September 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3045-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3045-2018 |
| Date reported | September 19, 2018 |
| Date initiated | July 19, 2018 |
| Recalling firm | Beaver Visitec |
| Firm location | Waltham, MA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3045-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026