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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64248

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ConMed Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

Z-0826-2013
Recall number
Z-0826-2013
Initiated
January 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
pouch. ConMed confirmed instances where the pouch seal was compromised
Sterility assurance reason.sterility_assurance · v1.0.0
sterile pouch. ConMed confirmed instances where the pouch seal was compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

Code information

Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.

device · product 2 of 2

ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

Z-0827-2013
Recall number
Z-0827-2013
Initiated
January 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
pouch. ConMed confirmed instances where the pouch seal was compromised
Sterility assurance reason.sterility_assurance · v1.0.0
sterile pouch. ConMed confirmed instances where the pouch seal was compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

Code information

Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.