The Recall Desk

Manufacturer

Karl Storz Endoscopy

71 recalls in our database name Karl Storz Endoscopy as the manufacturing or recalling firm.

What the numbers show

Total
71
Critical
0
Severe
0
Most recent
2026-07-29

Of the 71 recalls from Karl Storz Endoscopy we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–71 of 71

  • HighFDA (Devices)·Z-1054-2022·2022-05-18

    KARL STORZ Nasopharyngolaryngoscope Disinfection Failure Affects 14 States

    The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.

    Product
    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2022·2022-01-05

    Karl Storz Endoscope Sterilization Trays Instructions for Use Updated

    Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.

    Product
    Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELES
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0184-2022·2021-11-10

    Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure

    Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.

    Product
    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2897-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.

    Product
    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions

    Karl Storz is recalling 650 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid patient infection.

    Product
    Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2891-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

    Product
    Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2892-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates

    Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.

    Product
    Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2896-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent incomplete sterilization.

    Product
    Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2895-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions

    Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2890-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update

    Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.

    Product
    Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2894-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions

    Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2020·2020-05-20

    Karl Storz Endoscopy Recalls Insufflation Tubing Due to Ethylene Oxide Residues

    Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.

    Product
    Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1618-2020·2020-04-08

    Karl Storz C-MAC Video Laryngoscope Recall Due to Loose Glass Cover

    Karl Storz is recalling 27,165 C-MAC Video Laryngoscopes because the glass cover at the distal end may become loose during use or reprocessing, potentially delaying procedures or requiring removal from the body.

    Product
    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2020·2020-04-01

    Karl Storz Fiberscope Recall Due to Incorrect Sterilization Instructions

    Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1530-2020·2020-04-01

    Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1531-2020·2020-04-01

    Karl Storz Flexible Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz is recalling 42 flexible neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz, Model # 11161C2, Flexible Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2447-2019·2019-09-11

    Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect

    Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.

    Product
    Flexible Intubation Fiberscope, Model # 11301AB1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0098-2018·2017-11-22

    Karl Storz Recalls Mislabeled High Flow Insufflation Tubing Pouches

    Karl Storz Endoscopy is recalling 496 boxes of High Flow Insufflation Tubing because some inner pouches are mislabeled with the wrong catalog number.

    Product
    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2016·2016-07-13

    Karl Storz Image1 SPIES X-LINK Camera Control Unit Recall

    Karl Storz Endoscopy is recalling Image1 SPIES X-LINK Camera Control Units due to potential electrical interference when used with specific camera heads and mediastinoscopes.

    Product
    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2039-2014·2014-07-16

    Karl Storz Recalls Essential NEO Audio/Visual Units Due to Overheating Cable

    Karl Storz Endoscopy is recalling 968 Essential NEO audio/visual integration units because the connected power cable could overheat, generate smoke, and cause the peripheral to stop working.

    Product
    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide