RegWardenFDA facility compliance records
Recall

Class I — Synergetics Inc

Recalling firmSYNERGETICS, INC.
Registered facilitySYNERGETICS, INC. (the firm's only registered facility)
ClassificationClass I
StatusOngoing
ReasonSterilization certificates could not be validated by the supplier
ProductBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Quantity14 units
DistributionUS Nationwide
Initiated2024-06-12
Classified2024-07-11
Recall numberZ-2251-2024
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 I recall — Synergetics Inc (Z-2251-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94793/

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