Mechatronics USA FDA Record
- No warning letters matched by name
Mechatronics USA has 2 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mechatronics USA" is on file.
- Latest recall
- Z-1695-2023 · Class III · Apr 14, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 2 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 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-1695-2023 | Class III | RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control… | Apr 14, 2023 |
| Z-1694-2023 | Class III | RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality… | Apr 14, 2023 |
Mechatronics USA and the FDA: common questions
Has Mechatronics USA received an FDA warning letter?
No FDA warning letter addressed to the name "Mechatronics USA" 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 Mechatronics USA received an FDA Form 483?
FDA has not published a Form 483 for "Mechatronics USA" in its reading room. FDA publishes some Form 483s, not all of them.
Has Mechatronics USA had an FDA recall?
Yes. Mechatronics USA has 2 FDA recalls on record. The most recent started Apr 14, 2023.
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