Lower risk Medical device recall · FDA · Published October 15, 2021

Karl Storz Udel Sterilization Trays: Updated Sterilization Instructions for Safety

Karl Storz recalls specific sterilization trays with outdated instructions that may affect sterilization effectiveness. Updated instructions now specify compatible endoscope sizes and exclude ethylene oxide as a sterilization method.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0442-2022Medical device Karl Storz ›

Lower-risk recall

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 maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

Take action

Contact the company

Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017

✎ GovInfoNow plain-language explainer

Karl Storz is recalling certain sterilization trays due to outdated instructions that could lead to improper sterilization. The updated instructions now specify which endoscopes can be safely used with these trays and exclude ethylene oxide as a sterilization method. Read more at govinfonow.com/recall/61677-karl-storz-udel-sterilization-trays-updated-sterilization-instructions-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/61677-karl-storz-udel-sterilization-trays-updated-sterilization-instructions-for-safety · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0442-2022

Cite this page

“Karl Storz Udel Sterilization Trays: Updated Sterilization Instructions for Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61677-karl-storz-udel-sterilization-trays-updated-sterilization-instructions-for-safety. Based on FDA recall #Z-0442-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2022%22&limit=1).

The FDA announced on Oct. 15, 2021, that Karl Storz Endoscopy is recalling its Udel Sterilization Tray Instructions for Use due to sterilization effectiveness concerns. The agency issued recall number Z-0442-2022 for the affected documentation.

How to tell if you have it

Brand: Karl Storz
Product: Karl Storz Udel Sterilization Tray Instructions for Use
Part Numbers/Descriptions: 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 TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)
Lot Code: All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)

The hazard

According to the FDA, the recalled instructions for use were updated to ensure sterilization effectiveness. The new guidance states that udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and a maximum length of 845mm, and excludes ethylene oxide as a sterilization modality.

Context

GovInfoNow's records show Karl Storz Endoscopy has issued 24 other recalls since Oct. 10, 2017. Recent brand recalls include the Aug. 12, 2026, Karl Storz HOPKINS Telescope Recall for incorrect eyepiece packaging labels and the May 21, 2026, Flexible Hystero-Fiberscope Kits recall for expired sterility seal risks. Other recent recalls of similar products include the March 16, 2026, SurgiSmoke Flamingo Funnel Small Non-Gamma Sterilization Drape Hazard and the May 5, 2026, Olympus Ellik Evacuator Sterilization Risk.

How to tell if you have this one

Check for part numbers like 39301ACTS, 39301AS, 39301BCTS, and others listed in the recall notice. These trays were sold with instructions prior to PI-000078-10.0 (June 21, 2021).

Brand
Karl Storz
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Instructions for Use
Review the instructions for use on the tray to confirm they were issued before PI-000078-10.0 (June 21, 2021).

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: AK, AL, AP, 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 OUS: Canada, Venezuela,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

Oct 15, 2021Firm started the recall
Dec 29, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything with these trays?

The recall does not require immediate action, but you should check the instructions for use to confirm they were issued before June 21, 2021. If they were, you may need to follow the updated instructions for proper sterilization.

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Link to this recall

<a href="https://govinfonow.com/recall/61677-karl-storz-udel-sterilization-trays-updated-sterilization-instructions-for-safety">Karl Storz Udel Sterilization Trays: Updated Sterilization Instructions for Safety (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0442-2022 (October 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0442-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.