Reported Jun 28, 2023 · Ongoing
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- KARL STORZ Radel Sterilization Trays
- Models
27717A27717B39301A39301C39231XA39301C139311A39317A
- Lot codes and dates
- Model - UDI-DI/GTIN
27717A - 404855108926227717B - 404855108928639301A - 404855115695739301C - 404855115704639231XA39301C139311A39317A. All Lots
- Model - UDI-DI/GTIN
- Amount recalled
- 4,386
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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