Z-0144-04

Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220...

Name: Z-0144-04 Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220...
Creator: ConMed Electrosurgery
Published: 2003-09-15
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2003-09-15 / Terminated

FDA source

ConMed Electrosurgery began a recall of Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230 on 2003-09-15. The reason FDA records is "The Hyfrecator 2000 units were released without documented adherence to their voltage output specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0144-04
Status: Terminated
Initiated: 2003-09-15
Posted: 2003-11-19
Terminated: 2004-07-01
Recalling firm: ConMed Corporation
Product: Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
FDA root cause: Other
Action: All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.
Quantity in commerce: 10 units
Distribution: Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.
Product codes and lots: Serial numbers: 01AGJ199, 01AGJ262, 01DGJ251, 01EGJ125, 01JGJ177, 01MGJ243, 02CGJ244, 02EGJ160, 02EGJ311 and 02LGJ211.

Product code GEI

K970493Class IIHyfrecator 2000Aspen Labs / cleared 1997-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)