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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65969

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

Open FDA event record

Event summary

Timeline bucket
July 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synergetics 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

Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.

Z-0051-2014
Recall number
Z-0051-2014
Initiated
July 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synergetics Inc
Quantity
48/6-cannula boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.

Code information

Lot number: M222240

Distribution pattern

Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.