Medtronic Puerto Rico Operations Co. FDA Record
Medtronic Puerto Rico Operations Co. has 0 FDA recalls, 25 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Medtronic Puerto Rico Operations Co., the most recent on Aug 23, 2018.
- Latest recall
- Z-0304-2027 · Sep 24, 2026 · filed under Medtronic
- Latest inspection
- Mar 14, 2025 · 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 | 25 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 1 | 0 | 0 |
| 2017 | 4 | 0 | 0 | 0 | 0 |
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Medtronic Puerto Rico Operations Co. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 23, 2018 | |||
| Jun 1, 2009 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| Oct 25, 2019 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
| May 31, 2019 | Humacao, PR | Devices | Voluntary Action Indicated (VAI) | 2647346 |
| Feb 21, 2019 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
| May 15, 2018 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| Aug 29, 2017 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
| Jun 2, 2017 | Villalba, PR | Devices | No Action Indicated (NAI) | 2649622 |
| Mar 31, 2017 | Humacao, PR | Devices | Voluntary Action Indicated (VAI) | 2647346 |
| Feb 17, 2017 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
| Jun 14, 2016 | Villalba, PR | Devices | No Action Indicated (NAI) | 2649622 |
| Apr 28, 2016 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
| Nov 19, 2014 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| Jun 3, 2014 | Villalba, PR | Devices | No Action Indicated (NAI) | 2649622 |
| Oct 25, 2013 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| Jul 16, 2013 | Humacao, PR | Devices | No Action Indicated (NAI) | 2647346 |
| Aug 24, 2012 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| Nov 9, 2011 | Juncos, PR | Devices | No Action Indicated (NAI) | 3004369318 |
| May 20, 2011 | Villalba, PR | Devices | Voluntary Action Indicated (VAI) | 2649622 |
| May 13, 2011 | Humacao, PR | Devices | Voluntary Action Indicated (VAI) | 2647346 |
| May 11, 2011 | Juncos, PR | Devices | Voluntary Action Indicated (VAI) | 3004369318 |
- 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.
Compliance Actions
FDA's compliance actions data lists 2 compliance actions under Medtronic Puerto Rico Operations Co.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004369318 | Juncos, PR | 14 | Mar 14, 2025 |
| FEI 2647346 | Humacao, PR | 5 | May 31, 2019 |
| FEI 2649622 | Villalba, PR | 6 | Jun 2, 2017 |
Medtronic Puerto Rico Operations Co. and the FDA: common questions
Has Medtronic Puerto Rico Operations Co. received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Medtronic Puerto Rico Operations Co.. The most recent is dated Aug 23, 2018.
Has Medtronic Puerto Rico Operations Co. received an FDA Form 483?
FDA has not published a Form 483 for "Medtronic Puerto Rico Operations Co." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Medtronic Puerto Rico Operations Co.?
The most recent FDA inspection on file ended Mar 14, 2025 at Juncos, PR and was classified NAI. FDA has 25 inspections of Medtronic Puerto Rico Operations Co. on file, 1 of them classified OAI (official action indicated).
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