Z-1981-2023Class II

KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

Name: Z-1981-2023 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Creator: Karl Storz Endoscopy
Published: 2023-04-05
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2023-04-05 / Open, Classified / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy began a recall of KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A on 2023-04-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1981-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2023-06-21
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
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
Quantity in commerce: 4,386
Distribution: 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.
Product codes and lots: Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39231XA, 39301C1, 39311A, 39317A. All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1981-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-21

Product code KCT

K203572Class IIKarl Storz Radel Sterilization TraysKarl Storz Endoscopy America, Inc. / cleared 2021-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)