FDA Device recall Z-1981-2023
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
- FDA Device
- Class II
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A by Karl Storz Endoscopy, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1981-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-05 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Reason
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.
Identifiers
| code_info | Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39…Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39231XA, 39301C1, 39311A, 39317A. All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1981-2023%22
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