Reported Dec 27, 2023 · Ongoing
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal…
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?
- Injection Needle, curved 23 cm
- REF8598A; Injection Needle, straight, 23 cm
- REF
8598BInjection Needledistal 45-degrees23 cm
- REF8598D
- Lot codes and dates
- REF/UDI-DI
8598A/040485512132788598B/040485510014628598D/04048551213285 All lot numbers
- REF/UDI-DI
- Amount recalled
- 4,878
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
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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