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Sign in to claim this brandMicrotek Medical LLC
United States·US-MF-000019222
Last updated September 17, 2026
Information
- Country
- United States
- Address
- Three, Lakes Drive, Northfield, United States
- Website
- www.microtekmed.com
- —
- —
- [email protected]
- Phone
- 1-800-Medline
- PRRC Contact
- Lam Duong
- EUDAMED SRN
- US-MF-000019222
- FDA FEI Number
- 3014342658
- DUNS Number
- 106908437
Catalogue (1418)
Page 1 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Medline-Microtek | Equipment Drapes | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
| Microtek | 1 | FDA UDI | Class II | Active |
Related Companies
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (25)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 13, 2025 | Z-1963-2025 | — | open, classified | Due to non-sterile products being labeled as sterile |
| Jun 3, 2024 | Z-2643-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2639-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2640-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2642-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 3, 2024 | Z-2641-2024 | — | open, classified | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. |
| Jun 23, 2023 | Z-2251-2023 | — | open, classified | Certain lots of the products have a Naphthalene odor. |
| Jun 23, 2023 | Z-2250-2023 | — | open, classified | Certain lots of the products have a Naphthalene odor. |
| Apr 8, 2022 | Z-1071-2022 | — | terminated | Latex content in product was labeled incorrectly as latex free. |
| Mar 10, 2015 | Z-1348-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1342-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1349-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1344-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1337-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1346-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1341-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1339-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1347-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1343-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1340-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1338-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Mar 10, 2015 | Z-1345-2015 | — | terminated | This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Jan 5, 2011 | Z-1885-2011 | — | terminated | Product contains Triad Lubricating Jelly which was recalled. |
| Aug 23, 2010 | Z-0592-2011 | — | terminated | This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization. |
| May 25, 2010 | Z-2109-2010 | — | terminated | Product labeled as sterile was distributed without sterilization. |