Facility

FridaBaby LLC

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

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005630901
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	82 NE 26th St Miami, FL, US 33137
Registration status	Active · expires 2026
Parent company	Fridababy, LLC (owner-operator 10052488)
Brand names	Frida Fertility Early Detection Pregnancy Test; Ovulation and Pregnancy Test + Track Set

Activity by year

Recalls (1)

Devices registered here (2)

Kit, Test, Pregnancy, Hcg, Over The Counter
Product code LCX (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155
Visual, Pregnancy Hcg, Prescription Use
Product code JHI (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155

Recalls & enforcement

Class IIOngoing2020-01-27
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasion…

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. “FridaBaby LLC (FEI 3005630901) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005630901-fridababy-llc/

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