RegWardenFDA facility compliance records
Recall

Class II — Ethicon, Inc.

Recalling firmETHICON INC.
Registered facilityView this company's 11 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonLots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
ProductPERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
Quantity99,612 eaches
DistributionNo domestic distribution. Foreign distribution to Algeria Angola Australia Austria Azerbaijan Bahrain Belgium Bosnia and Herzegovina Canada Chad Chile Czechia Egypt Finland France Gabon Germany Greece Hong Kong Iceland India Iran Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Lebanon Libya Lithuania Mauritius Morocco Mozambique Netherlands (the) New Cale…
Initiated2020-06-10
Classified2020-07-02
Recall numberZ-2486-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ethicon, Inc. (Z-2486-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85820/

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