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
ReasonProduct may contain the incorrect material which could impact treatment.
ProductPDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Quantity88 boxes (1056 ea)
DistributionDistribution in Japan only
Initiated2022-08-08
Classified2022-09-20
Recall numberZ-1773-2022
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-1773-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90764/

Not open yet

Alerts for ETHICON INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.