CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report
Loop, Cutting, Angled/6) recalled by Karl Storz Endoscopy America
Karl Storz Endoscopy America is recalling Loop, Cutting, Angled/6), distributed nationwide in the US. The recall was initiated on 1 Jun 2009 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1316-2013
- FDA event ID
- 55358
- Recalling firm
- Karl Storz Endoscopy America, El Segundo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2009
- FDA classified
- 11 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2009 | Recall initiated by company | |
| 11 May 2013 | Classified by FDA | +1440 days |
| 22 May 2013 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Where it was distributed
Distributed Nationwide and in Canada.
Questions about this recall
Is Loop, Cutting, Angled/6) recalled?
Yes. Karl Storz Endoscopy America recalled Loop, Cutting, Angled/6) on 1 Jun 2009. The recall is Class II and its status is Terminated. Recall number Z-1316-2013.
Why was it recalled?
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Which lots are affected?
Lot 36815
Where was it sold?
Distributed Nationwide and in Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Karl Storz Endoscopy America
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intubation Flexible Fiberscope recalled by Karl Storz Endoscopy America | Karl Storz Endoscopy America | Foreign Material | Nationwide |
| Device | CLASS II | Broncho Flexible Fiberscope recalled by Karl Storz Endoscopy America | Karl Storz Endoscopy America | Foreign Material | Nationwide |
| Device | CLASS II | Axillent Debakey Grasping Forceps recalled | Karl Storz Endoscopy America | Labeling Errors | Nationwide |
| Device | CLASS II | 27023WU Balloon Catheter., 2/pkg, sterile, contains latex recalled | Karl Storz Endoscopy America | Sterility | 5 states |
| Device | CLASS II | Electrode, Barrel Bar (27050NX/6) recalled | Karl Storz Endoscopy America | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |