RegWardenFDA facility compliance records
Facility

Biomedical Polymers, Inc.

1 recall(s) on record — most severe on record: Class III.

Activity by year

FDA actions on record by year2019: 1 recalls20172018120192020202120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • At Home Intravaginal Insemination System
    Product code QYZ (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.6110

Recalls & enforcement

  • Class IIITerminated2019-09-18
    The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Biomedical Polymers, Inc. (FEI 1220502) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220502-biomedical-polymers-inc/

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