Karl Storz Endoscopy-America, Inc.
Country not established FDA establishment FEI 3007475226
- Devices
- 369
- Registrations
- FDA
- FDA recalls
- 17
What Karl Storz Endoscopy-America, Inc. makes
Karl Storz Endoscopy-America, Inc. manufactures endoscopic instruments and systems for otolaryngology, urology, cochlear implantation, and proctology, including laryngoscopes, flexible ureterorenoscopes, snares, micro-instruments, and endoscopic dissection tools. Their portfolio also includes imaging devices like the SPIES 3D Tip Camera and accessories for procedures such as endopyelotomy and proctoscopy.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the 510(k) clearance database. The manufacturer is based in the United States.
Catalogue
Search and filter all 369 devicesShowing 1-50 of 369
Company details
- FDA FEI number
- 3007475226
- Address
- 2151 E. Grand Avenue, El Segundo, CA, 90245
FDA recalls
FDA recall records list 17 recalls initiated by Karl Storz Endoscopy-America, Inc., the earliest on 2009-06-01 and the most recent on 2013-11-13. By recorded status: 17 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 13 Nov 2013 Z-0526-2014 Class II Terminated KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.
- 13 Nov 2013 Z-0527-2014 Class II Terminated KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.
- 6 Nov 2013 Z-0465-2014 Class II Terminated KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
- 31 May 2013 Z-1728-2013 Class II Terminated Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
2012
- 16 Aug 2012 Z-1216-2013 Class II Terminated The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.
2009
- 1 Jun 2009 Z-1305-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1306-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1307-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1308-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1309-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Show all 17 recalls
2009
- 1 Jun 2009 Z-1310-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1311-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1312-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1313-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1314-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1315-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- 1 Jun 2009 Z-1316-2013 Class II Terminated Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Frequently asked questions
How many devices does Karl Storz Endoscopy-America, Inc. have in the registry?
The registry currently lists 369 devices for Karl Storz Endoscopy-America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karl Storz Endoscopy-America, Inc.'s devices?
Among its 50 most recently registered devices, Karl Storz Endoscopy-America, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Karl Storz Endoscopy-America, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Karl Storz Endoscopy-America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Karl Storz Endoscopy-America, Inc.?
FDA recall records list 17 recalls initiated by Karl Storz Endoscopy-America, Inc., the most recent initiated on 2013-11-13. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Karl Storz Endoscopy-America, Inc. in the registry?
The most recently registered devices listed for Karl Storz Endoscopy-America, Inc. include KARL STORZ Laryngoscopes and Accessories, KSEA DION-GRACIA SET, KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE and STORZ SLX-F2 STORM TOUCH.