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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68495

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

Open FDA event record

Event summary

Timeline bucket
May 12, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microline Surgical, 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

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

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221

Z-1986-2014
Recall number
Z-1986-2014
Initiated
May 12, 2014
Classification
Class II
Status
Terminated
Recalling firm
Microline Surgical, Inc.
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Fenestrated Grasper Tip jaw to 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

Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

Code information

Lot Numbers: 00115342

Distribution pattern

Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.

device · product 2 of 2

Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222

Z-1987-2014
Recall number
Z-1987-2014
Initiated
May 12, 2014
Classification
Class II
Status
Terminated
Recalling firm
Microline Surgical, Inc.
Quantity
6290 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Fenestrated Grasper Tip jaw to 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

Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

Code information

Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278

Distribution pattern

Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.