Bard Shannon Limited FDA Record
Bard Shannon Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bard Shannon Limited" is on file.
- Latest recall
- Z-3275-2026 · Aug 20, 2026 · filed under Bard Peripheral Vascular
- Latest inspection
- Aug 18, 2023 · NAI
Newer recall under related name Bard Peripheral Vascular: Aug 20, 2026, Z-3275-2026.
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 | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 18, 2023 | Rio Abajo HUMACAO, PR | Devices | No Action Indicated (NAI) | 3005636544 |
| Nov 21, 2018 | Rio Abajo HUMACAO, PR | Devices | Voluntary Action Indicated (VAI) | 3005636544 |
| Jan 22, 2016 | Rio Abajo HUMACAO, PR | Devices | No Action Indicated (NAI) | 3005636544 |
| Nov 21, 2013 | Rio Abajo HUMACAO, PR | Devices | No Action Indicated (NAI) | 3005636544 |
| Apr 14, 2010 | Rio Abajo HUMACAO, PR | Devices | No Action Indicated (NAI) | 3005636544 |
| Oct 9, 2009 | Rio Abajo HUMACAO, PR | Devices | No Action Indicated (NAI) | 3005636544 |
- 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 3005636544 | Rio Abajo HUMACAO, PR | 6 | Aug 18, 2023 |
Bard Shannon Limited and the FDA: common questions
Has Bard Shannon Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Bard Shannon Limited" 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 Bard Shannon Limited received an FDA Form 483?
FDA has not published a Form 483 for "Bard Shannon Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bard Shannon Limited?
The most recent FDA inspection on file ended Aug 18, 2023 at Rio Abajo HUMACAO, PR and was classified NAI. FDA has 6 inspections of Bard Shannon Limited on file.
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