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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 55358

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

Open FDA event record

Event summary

Timeline bucket
June 01, 2009
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Karl Storz Endoscopy America 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

12 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 12

Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1305-2013
Recall number
Z-1305-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36775, 36786, 36828, 36864

Distribution pattern

Distributed Nationwide and in Canada.

device · product 2 of 12

Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1306-2013
Recall number
Z-1306-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36785, 36827

Distribution pattern

Distributed Nationwide and in Canada.

device · product 3 of 12

Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1307-2013
Recall number
Z-1307-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36829

Distribution pattern

Distributed Nationwide and in Canada.

device · product 4 of 12

Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1308-2013
Recall number
Z-1308-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36832

Distribution pattern

Distributed Nationwide and in Canada.

device · product 5 of 12

Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1309-2013
Recall number
Z-1309-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36833

Distribution pattern

Distributed Nationwide and in Canada.

device · product 6 of 12

Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1310-2013
Recall number
Z-1310-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36850

Distribution pattern

Distributed Nationwide and in Canada.

device · product 7 of 12

Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1311-2013
Recall number
Z-1311-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36835

Distribution pattern

Distributed Nationwide and in Canada.

device · product 8 of 12

Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1312-2013
Recall number
Z-1312-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36836

Distribution pattern

Distributed Nationwide and in Canada.

device · product 9 of 12

Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1313-2013
Recall number
Z-1313-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36781

Distribution pattern

Distributed Nationwide and in Canada.

device · product 10 of 12

Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1314-2013
Recall number
Z-1314-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36851

Distribution pattern

Distributed Nationwide and in Canada.

device · product 11 of 12

Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1315-2013
Recall number
Z-1315-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36897

Distribution pattern

Distributed Nationwide and in Canada.

device · product 12 of 12

Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Z-1316-2013
Recall number
Z-1316-2013
Initiated
June 01, 2009
Classification
Class II
Status
Terminated
Quantity
9432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Code information

Lot 36815

Distribution pattern

Distributed Nationwide and in Canada.