Contract Medical International GmbH FDA Record
- Latest inspection VAI · May 11, 2023
- No warning letters matched by name
Contract Medical International GmbH has 1 FDA recall, 1 inspection, 7 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Contract Medical International GmbH" is on file.
- Latest recall
- Z-2532-2025 · Class II · Jul 30, 2025
- Latest inspection
- May 11, 2023 · VAI
- Latest 510(k)
- Mar 16, 2025
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 | 7 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Contract Medical International GmbH: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2532-2025 | Class II | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System… | Jul 30, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 11, 2023 | Dresden, Germany | Devices | Voluntary Action Indicated (VAI) | 3003637635 |
- 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 3003637635 | Dresden, Germany | 1 | May 11, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm… | Mar 16, 2025 |
| K240957 | Catapult Guide Sheath | Aug 14, 2024 |
| K221914 | Catapult Guide Sheath | Jul 29, 2022 |
| K203179 | Fortress Introducer Sheath System | Nov 20, 2020 |
| K181463 | DuraSheath Introducer Sheath System | Dec 13, 2018 |
| K153197 | Fortress Introducer Sheath SYstem | Jan 11, 2016 |
| K142357 | DuraSheath Introducer Sheath System | Jun 25, 2015 |
Contract Medical International GmbH and the FDA: common questions
Has Contract Medical International GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Contract Medical International GmbH" 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 Contract Medical International GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Contract Medical International GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Contract Medical International GmbH?
The most recent FDA inspection on file ended May 11, 2023 at Dresden, Germany and was classified VAI. FDA has 1 inspection of Contract Medical International GmbH on file.
Has Contract Medical International GmbH had an FDA recall?
Yes. Contract Medical International GmbH has 1 FDA recall on record. The most recent started Jul 30, 2025.
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