COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L." and its spelling variant "Covidien Formerly Mallinckrodt Dar". Records filed under related names are not included; see Related names.

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

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Mar 21, 2012.

DateSiteProductClassificationFEI
Mar 21, 2012Mirandola, ItalyDevicesNo 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002808696Mirandola, Italy1Mar 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.