Karl Storz Endoscopy-america, Inc.
28 Millbury Street, Auburn, MA, US
Registered product codes
207 product codes
Recent MDR events
421 on file
- HD VIDEO RHINO-LARYNGOSCOPE, 3.7 MMJul 6, 2026Malfunction1221826-2026-01541
- RESECTOSCOPEJun 4, 2026InjuryMW5188975
- TELE PACK X LED MONITOR 15" LCD ZMay 13, 2026MalfunctionMW5188196
- MONOPOLAR SPATULAApr 20, 2026InjuryMW5186973
- RIGID BRONCHOSCOPY ENDOSCOPES AND INSTRUMENTSMar 24, 2026MalfunctionMW5185737
- RIGID BRONCHOSCOPY ENDOSCOPES AND INSTRUMENTSMar 24, 2026MalfunctionMW5185738
- RIGID BRONCHOSCOPY ENDOSCOPES AND INSTRUMENTSMar 24, 2026MalfunctionMW5185739
- STORZ MONOPOLAR NEEDLEMar 19, 2026MalfunctionMW5185412
- N.A.Feb 10, 2026Malfunction24303704
- LAPAROSCOPE, GENERAL & PLASTIC SURGERYJan 26, 2026MalfunctionMW5182789
Recalls
19 on file
- TerminatedDec 17, 2013
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.
View FDA record ↗ - TerminatedDec 17, 2013
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.
View FDA record ↗ - TerminatedDec 6, 2013
KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
View FDA record ↗ - TerminatedJul 13, 2013
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.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗ - TerminatedMay 11, 2013
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
View FDA record ↗
Compliance history
Matched by FEI 2020550.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 15, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.40(a)Feb 15, 2024
Report of death, injury
- 21 CFR 820.100(b)Feb 15, 2024
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.