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Karl Storz Endoscopy Recalls
71 recalls on record · July 16, 2014 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be us
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
May 20, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Hazard: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
April 8, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which incl
Hazard: The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.
April 1, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Hazard: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
April 1, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz, Model # 11161C2, Flexible Neuroscope
Hazard: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
April 1, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Hazard: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
September 11, 2019Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Fiberscope, Model # 11301AB1
Hazard: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
September 4, 2019Medical DevicesFDA
Karl Storz Endoscopy recalls FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Hazard: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
November 22, 2017Medical DevicesFDA
Karl Storz Endoscopy recalls STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also
Hazard: The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
July 13, 2016Medical DevicesFDA
Karl Storz Endoscopy recalls Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Prod
Hazard: Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).
July 16, 2014Medical DevicesFDA
Karl Storz Endoscopy recalls Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
Hazard: KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.