RegWardenFDA facility compliance records
Company

SYNERGETICS, INC.

4 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 2 recalls; 2016: 1 recalls; 2024: 1 recalls2’13’14’151’16’17’18’19’20’21’22’231’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2024-06-12
    Sterilization certificates could not be validated by the supplier
  • Class IITerminated2016-08-11
    Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
  • Class IITerminated2013-12-09
    Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
  • Class IITerminated2013-07-30
    One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SYNERGETICS, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9005675-synergetics-inc/

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