Covidien Medical Products (Shanghai) Manufacturing L.L.C. FDA Record
- Latest inspection NAI · Feb 20, 2014
- No warning letters matched by name
Covidien Medical Products (Shanghai) Manufacturing L.L.C. has 1 FDA recall, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Covidien Medical Products (Shanghai) Manufacturing L.L.C." is on file.
- Latest recall
- Z-0304-2027 · Sep 24, 2026 · filed under Medtronic
- Latest recall under this name
- Z-1187-2016 · Class II · Feb 23, 2016
- Latest inspection
- Feb 20, 2014 · NAI
Newer recall under related name Medtronic: Sep 24, 2026, Z-0304-2027.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | 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 | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Covidien Medical Products (Shanghai) Manufacturing L.L.C. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Covidien Medical Products (Shanghai) Manufacturing L.L.C. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1187-2016 | Class II | Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with… | Feb 23, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 20, 2014 | Shanghai, China | Devices | No Action Indicated (NAI) | 3006451981 |
| Oct 21, 2010 | Shanghai, China | Devices | No Action Indicated (NAI) | 3006451981 |
- 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 3006451981 | Shanghai, China | 2 | Feb 20, 2014 |
Covidien Medical Products (Shanghai) Manufacturing L.L.C. and the FDA: common questions
Has Covidien Medical Products (Shanghai) Manufacturing L.L.C. received an FDA warning letter?
No FDA warning letter addressed to the name "Covidien Medical Products (Shanghai) Manufacturing L.L.C." 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 Medical Products (Shanghai) Manufacturing L.L.C. received an FDA Form 483?
FDA has not published a Form 483 for "Covidien Medical Products (Shanghai) Manufacturing L.L.C." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Covidien Medical Products (Shanghai) Manufacturing L.L.C.?
The most recent FDA inspection on file ended Feb 20, 2014 at Shanghai, China and was classified NAI. FDA has 2 inspections of Covidien Medical Products (Shanghai) Manufacturing L.L.C. on file.
Has Covidien Medical Products (Shanghai) Manufacturing L.L.C. had an FDA recall?
Yes. Covidien Medical Products (Shanghai) Manufacturing L.L.C. has 1 FDA recall on record. The most recent under this name started Feb 23, 2016. A newer recall, dated Sep 24, 2026, is filed under the related name Medtronic.
Need more than this page shows? Ask about Covidien Medical Products (Shanghai) Manufacturing L.L.C. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.