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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68012

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

Open FDA event record

Event summary

Timeline bucket
April 14, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microline Surgical

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

Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

Z-1635-2014
Recall number
Z-1635-2014
Initiated
April 14, 2014
Classification
Class II
Status
Terminated
Recalling firm
Microline Surgical
Quantity
540 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Grasper jaw may break when force is applied to the jaw

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Grasper jaw may break when force is applied to the jaw

Code information

Lot Numbers: 00116169 and 00115866

Distribution pattern

Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.