Reported Jun 28, 2023 · Ongoing
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm,…
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?
16 products · 16 lot codes
11580AMetal Tray, 178 x 135 x 37 mm
1 recalled lot code
04048551051801
11580BMetal Tray, 275 x 178 x 35 mm
1 recalled lot code
04048551051818
11580CMetal Tray, 373 x 178 x 35 mm
1 recalled lot code
04048551051825
11580DMetal Tray, 275 x 175 x 37 mm
1 recalled lot code
04048551051832
Page 1 of 4
- Amount recalled
- 4,933
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
Metal 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.
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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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