Recall archive / FDA device enforcement
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD... — FDA record Z-0442-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 15, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 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)
- 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 maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
- Classification
- Class II
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 71892
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0442-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots with Instructions for Use Prior to PI-000078-10.0 (06/21) |
Match all identifying details in the current notice. A brand name alone is not enough.
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, Barbados, GUAM, Puerto Rico, Mexico, Northern Mariana Islands, Trinidad & Tobago, Germany, Cayman Islands, Philippines, Japan, Dominican Republic, Panama, Bahamas, Ecuador, Suriname, American Virgin Islands, British Virgin Islands, Belize, Curacao, The Bahamas, Brazil, South Korea, Bermuda
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 5, 2022
- Recall initiation date
- Oct 15, 2021
- Center classification date
- Dec 29, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.