FDAApril 5, 2023device
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
karl storz endoscopykarlkarl storz
UPCs
4048551089262404855108928640485511569574048551157046
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.2026-03-23
- FDAKARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 01232024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE01232024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 01232024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE2024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 01232024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 01232024-12-19
- FDAKARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 01232024-12-19
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