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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63933

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 20, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Healthtronics, Inc.

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

1 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 1

HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.

Z-0825-2013
Recall number
Z-0825-2013
Initiated
December 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
Healthtronics, Inc.
Quantity
50 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label on the outer box has the incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

Code information

Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI