Recall archive
29 recalls · page 1 of 2
Reported Jul 29, 2026
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details · Reason for recall — Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal…
FDA (openFDA device enforcement)
Reported Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
FDA (openFDA device enforcement)
Reported Dec 4, 2024
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so…
FDA (openFDA device enforcement)
Reported Apr 10, 2024
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Inadequate reprocessing validation evidence
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Injection Needle, REF: 25207
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery,…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Reason for recall — Flexible intubation endoscopes sterility assurance can not be confirmed.
FDA (openFDA device enforcement)
Reported Jun 28, 2023
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2022
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details · Reason for recall — The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
FDA (openFDA device enforcement)
Reported May 18, 2022
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 5, 2022
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details · Reason for recall — To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible…
FDA (openFDA device enforcement)
Reported Nov 10, 2021
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Reason for recall — During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There…
FDA (openFDA device enforcement)
Reported Sep 2, 2020
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Reason for recall — Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is…
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Karl Storz Endoscopy
Matched: Brand — The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
FDA (openFDA device enforcement)
Reported Apr 8, 2020
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
Flexible Intubation Fiberscope, Model # 11301AB1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
FDA (openFDA device enforcement)
Reported Sep 4, 2019
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
FDA (openFDA device enforcement)
Reported Nov 22, 2017
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Product · Product details — The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand — Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
Matched: Brand · Reason for recall — KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke…
FDA (openFDA device enforcement)
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