Karl Storz Endoscopy: 71 FDA recall reports
Every medical device recall the FDA has published for Karl Storz Endoscopy. The fault, and how the agency graded it.
71Reports
0Class I
64Ongoing
2026-07-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal:
Z-2794-2026 · Class II · reported 2026-07-29 · Ongoing
- Why it was recalled
- Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
- Product
- Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- Where it went
- US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
- How much
- 45
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Z-1055-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 1510 units
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Z-1051-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
- Where it went
- US Nationwide distribution.
- How much
- 4 Units
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Z-1052-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
- Where it went
- US Nationwide distribution.
- How much
- 221 units
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Z-1057-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 59 units
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Z-1062-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 185 units
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Z-1053-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
- Where it went
- US Nationwide distribution.
- How much
- 185 units
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Z-1054-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 39 units
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Z-1056-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 65 units
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Z-1063-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 180 units
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Z-1061-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 82 units
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Z-1059-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 102 units
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Z-1064-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 299 units
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Z-1060-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 3069 Units
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Z-1058-2025 · Class II · reported 2025-02-05 · Ongoing
- Why it was recalled
- Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
- Where it went
- US Nationwide distribution.
- How much
- 5 units
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Z-0837-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
- Product
- Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
- Where it went
- US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
- How much
- 285 units
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, ste
Z-0526-2025 · Class II · reported 2024-12-04 · Ongoing
- Why it was recalled
- Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
- Product
- 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 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
- Where it went
- Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.
- How much
- 105 devices
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Z-0363-2025 · Class II · reported 2024-11-20 · Ongoing
- Why it was recalled
- 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.
- Product
- Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
- Where it went
- U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
- How much
- 40 units
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Z-3218-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 425 units
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Z-3219-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 34 units
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Z-3222-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 78 units
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Z-3220-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 1982 units
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Z-3223-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 59 UNITS
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Z-3221-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 109 UNITS
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Z-3225-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 1 unit
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Z-3224-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Product
- Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
- Where it went
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
- How much
- 5 units
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Z-1809-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
- Product
- LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
- Where it went
- Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
- How much
- 85
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Z-1473-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- Inadequate reprocessing validation evidence
- Product
- Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
- Where it went
- US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
- How much
- 27 units
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Z-1474-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- Inadequate reprocessing validation evidence
- Product
- Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
- Where it went
- US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
- How much
- 147 Units
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Z-1472-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- Inadequate reprocessing validation evidence
- Product
- Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
- Where it went
- US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
- How much
- 190 units
Showing the 30 most recent of 71. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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