COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. FDA Record
COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L." is on file.
- Latest recall
- Z-0304-2027 · Sep 24, 2026 · filed under Medtronic
- Latest inspection
- Mar 21, 2012 · NAI
Newer recall under related name Medtronic: Sep 24, 2026, Z-0304-2027.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 21, 2012 | Mirandola, Italy | Devices | No Action Indicated (NAI) | 3002808696 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808696 | Mirandola, Italy | 1 | Mar 21, 2012 |
COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. and the FDA: common questions
Has COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. received an FDA warning letter?
No FDA warning letter addressed to the name "COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L." 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 COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. received an FDA Form 483?
FDA has not published a Form 483 for "COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L.?
The most recent FDA inspection on file ended Mar 21, 2012 at Mirandola, Italy and was classified NAI. FDA has 1 inspection of COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. on file.
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