Karl Storz Endoscopy recalls
Karl Storz Endoscopy appears in 72 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy
Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. - Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS)
FDA Device · Class II · 2022-01-05 · Karl Storz Endoscopy
Reason: To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximu… - FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
FDA Device · Class II · 2021-11-10 · Karl Storz Endoscopy
Reason: During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infectio… - Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examina…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination…
FDA Device · Class II · 2020-09-02 · Karl Storz Endoscopy
Reason: 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 tot… - Insufflation tubing to be used with varies insufflator units
FDA Device · Class III · 2020-05-20 · Karl Storz Endoscopy
Reason: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. - Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX,…
FDA Device · Class II · 2020-04-08 · Karl Storz Endoscopy
Reason: 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,… - Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy
Reason: 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… - Karl Storz, Model # 11161C2, Flexible Neuroscope
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy
Reason: 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… - Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy
Reason: 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… - Flexible Intubation Fiberscope, Model # 11301AB1
FDA Device · Class II · 2019-09-11 · Karl Storz Endoscopy
Reason: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer. - FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
FDA Device · Class II · 2019-09-04 · Karl Storz Endoscopy
Reason: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. - STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer…
FDA Device · Class II · 2017-11-22 · Karl Storz Endoscopy
Reason: The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different 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…
FDA Device · Class II · 2016-07-13 · Karl Storz Endoscopy
Reason: 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). - Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit
FDA Device · Class II · 2014-07-16 · Karl Storz Endoscopy
Reason: 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…