RegWardenFDA facility compliance records
Company

BIOSEAL

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2019: 1 recalls; 2021: 1 recalls1201720181201920201202120222023202420252026
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class IICompleted2021-03-23
    Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
  • Class IITerminated2019-08-15
    The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size…
  • Class IICompleted2017-10-18
    Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

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. “BIOSEAL — 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-2027062-bioseal/

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