Z-1314-2013Class II

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

Name: Z-1314-2013 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives)
Creator: Karl Storz Endoscopy America Inc
Published: 2009-06-01
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2009-06-01 / Terminated / root cause: packaging

FDA source

Karl Storz Endoscopy America Inc began a recall of Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives) on 2009-06-01. FDA classified it as Class II and gives the reason as "Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1314-2013
Classification: Class II
Status: Terminated
Initiated: 2009-06-01
Posted: 2013-05-11
Terminated: 2013-05-13
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Product code: FJL Resectoscope
Reason for recall: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Root cause tag: packaging
FDA root cause: Packaging
Action: A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.
Quantity in commerce: 9432 units
Distribution: Distributed Nationwide and in Canada.
Product codes and lots: Lot 36851

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1305-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1306-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1307-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1308-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1309-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1310-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1311-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1312-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1313-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1314-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1315-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1316-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11

Product code FJL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)