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Ethicon Endo Surgery, LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MPClass IIMar 7, 2025Identified curing issues with the silicone during the needle
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRMClass IIMar 7, 2025Identified curing issues with the silicone during the needle
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MHClass IIMar 7, 2025Identified curing issues with the silicone during the needle
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1Class IIMar 7, 2025Identified curing issues with the silicone during the needle

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