Pentax of America Inc recalls Pentax Video Colonoscope Model: EC38-i10L
- Recall date
- January 3, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1268-2020
- FDA classification
- Class II
- Brand / firm
- Pentax of America Inc
- Sold / distributed
- NC, MA
Why it was recalled
Distributed in the USA without an approved 510K
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pentax Video Colonoscope Model: EC38-i10L
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