Severity
Moderate
FDA Devices recall · Reported June 25, 2014
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
ConMed Corporation recalled Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 … - a moderate-severity action.
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 … was recalled by ConMed Corporation in June 25, 2014. Reason: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces …. Check the official notice for the remedy. Verify recall #Z-1839-2014 with the FDA Devices before acting.
The recall
ConMed Corporation issued this moderate-severity FDA Devices recall-ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1839-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1839-2014) was formally reported on June 25, 2014, with the manufacturer initiating the action on February 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. ConMed Corporation is listed as the recalling firm, operating out of Utica, NY. Federal records list the affected scope as 12,653 units (10,769 domestically & 1,884 internationally).
The documented reason for this recall is: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. Distribution data in the federal record shows the product reached: Worldwide Distribution.. Distribution scope 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, 3 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.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Severity
Moderate
Affected scope
12,653 units (10,769 domestically & 1,884 internationally)
Related Recalls
6
3 from same agency
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1839-2014 |
| Date reported | June 25, 2014 |
| Date initiated | February 20, 2014 |
| Recalling firm | ConMed Corporation |
| Firm location | Utica, NY |
| Affected scope | 12,653 units (10,769 domestically & 1,884 internationally) |
| Distribution | Worldwide Distribution. |
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.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 25, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.