FDA-Device2017-08-23Class II
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Hazard
Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
Sold states
Worldwide
Affected count
305,779 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3043-2017More Boston Scientific Corporation recalls
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- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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