Fridababy LLC FDA Record
- No warning letters matched by name
Fridababy LLC has 1 FDA recall, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Fridababy LLC" is on file.
- Latest recall
- Z-1103-2020 · Class II · Jan 27, 2020
- Latest 510(k)
- Jun 29, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1103-2020 | Class II | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once | Jan 27, 2020 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K220289 | FridaMom Anti-Nausea Bands | Jun 29, 2022 |
Fridababy LLC and the FDA: common questions
Has Fridababy LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Fridababy LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Fridababy LLC received an FDA Form 483?
FDA has not published a Form 483 for "Fridababy LLC" in its reading room. FDA publishes some Form 483s, not all of them.
Has Fridababy LLC had an FDA recall?
Yes. Fridababy LLC has 1 FDA recall on record. The most recent started Jan 27, 2020.
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