KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
FDA Recall Z-1981-2023 · Posted 2023-06-21
Recalling FirmKarl Storz Endoscopy
Recall StatusOpen, Classified
Product CodeKCT
Date Initiated2023-04-05
Product Quantity4,386
Reason for Recall
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Firm Action
On 4/5/23, correction notices were sent to customers informing them that new instructions for use were available: https://spwebspace.karlstorz.com/sites/RadelTrays/SitePages/Home.aspx
1) Ensure all relevant personnel in your organization review the notice and new Instructions for Use.
2) If you have previously sold or transferred any of the affected trays to a third party, please forward this notice to all such third parties.
3) Complete and return the acknowledgement form to [email protected]
Customers with questions can email [email protected]. The following recalling firm phone number was provided: 800-421-0837
Root Cause
No Marketing Application
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, RI, SC, VA, VT, AL, CO, GU, IA, ID, KY, ME, MN, MT, ND, NE, NJ, NM, OK, PR, SD, TN, UT, WA, WI, WV, WY and the country of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.