Karl Storz Endoscopy 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, Recall
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According to the U.S. Food and Drug Administration (FDA)
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,
Brand
Karl Storz Endoscopy
Lot Codes / Batch Numbers
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
Products Sold
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
Karl Storz Endoscopy is recalling Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAM due to To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/15/21 correction notices were mailed to customers. Customers were asked to do the following: 1) Ensure all personnel in your organization review this letter and the current instructions for use. If you have previously sold or transferred affected devices to a third party, please forward this notice to all such third parties. 2) Discard any prior versions of the instructions for use. 3) Complete and return the acknowledgment form. Customers with medical or safety-related inquiries can contact Medical Affairs at 1-800-649-8852 or medicalaffairs@karlstorz.com. Customers with questions about the correction communication are encouraged to call 1-866-913-0667 or email karlstorz7824@stericycle.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026