RegWardenFDA facility compliance records
Company

Convatec

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 2 recalls1’132’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2014-04-29
    Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Spec…
  • Class IITerminated2014-02-07
    The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
  • Class IIITerminated2013-06-25
    ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.

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. “Convatec — 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-10079255-convatec/

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