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Sign in to claim this brandMicrotek Medical LLC
United States·US-MF-000019222
Last updated September 17, 2026
What Microtek Medical LLC makes
Microtek Medical LLC manufactures single-use medical drapes for surgical and angiographic procedures, including sterile and non-sterile instrument/equipment drapes and patient drapes. Their portfolio also includes a reusable cardiopulmonary resuscitation (CPR) mask and a surgical fluid/smoke waste management suction unit. Additionally, they produce sterile body-surface ultrasound imaging transducer covers.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Microtek Medical LLC is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Microtek Medical LLC manufacture?
Microtek Medical LLC specializes in single-use medical drapes, including patient surgical drapes (both sterile and non-sterile), instrument/equipment drapes (sterile), angiographic drapes, and body-surface ultrasound imaging transducer covers. Their portfolio also includes a reusable cardiopulmonary resuscitation (CPR) mask and a surgical fluid/smoke waste management suction unit. These devices are designed for surgical and diagnostic procedures to maintain sterility and hygiene.
Where is Microtek Medical LLC based?
Microtek Medical LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations, including FDA requirements.
Which regulatory registries list Microtek Medical LLC’s devices?
Microtek Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details, including manufacturer information and classification.
How are Microtek Medical LLC’s devices classified under FDA regulations?
Microtek Medical LLC’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and require general controls for regulation, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
What distinguishes Microtek Medical LLC’s single-use drapes from reusable devices in their portfolio?
Microtek Medical LLC primarily manufactures single-use drapes, which are designed for one-time use to minimize infection risks in surgical and diagnostic settings. Their reusable device, the cardiopulmonary resuscitation (CPR) mask, is engineered for durability and repeated use in emergency medical scenarios. The distinction lies in their intended lifecycle and regulatory considerations, with single-use items emphasizing sterility per procedure and reusable items requiring cleaning and maintenance protocols.
AI-generated from registry data and not verified by a human reviewer.
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 20 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 |
| 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 |
| DePuy Synthes VELYS | 451570018 | 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 | Patient 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 |
| Medline-Microtek | Equipment Drapes | FDA UDI | Class II | Active |
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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.
Microtek Medical LLC has initiated 25 recall records between May 25, 2010, and April 13, 2025, with statuses including open, classified, and terminated. The reasons cited involve packaging defects (e.g., pin holes, tears in sterile barriers), labeling noncompliance (missing latex warnings, incorrect sterilization claims, mislabeled latex-free products), sterilization discrepancies (products distributed without sterilization or mislabeled sterilization methods), and odor anomalies (Naphthalene scent in certain lots). Some recalls also reference incorrect lubricant inclusion (Triad Lubricating Jelly).
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |