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Sign in to claim this brandMEDIVATORS INC.
United States·US-MF-000043422
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3150, Pollok Dr, Conroe, United States
- Website
- www.steris.com
- —
- —
- [email protected]
- Phone
- +1(800)444-4729
- PRRC Contact
- Zeeshan Shamim
- EUDAMED SRN
- US-MF-000043422
- FDA FEI Number
- 3003012447
- DUNS Number
- 068199363
Catalogue (5153)
Page 104 of 104| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Defendo Single Use Valve Kit | 100311 | EUDAMEDFDA UDI | Class I | Active |
| Defendo Single Use Valve Kit | 4003269 | EUDAMEDFDA UDI | Class I | Active |
| Defendo Single Use Valve Kit | 100323 | EUDAMEDFDA UDI | Class I | Active |
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Authorities
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FDA Recalls (9)
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 20, 2021 | Z-1859-2021 | — | terminated | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| Oct 9, 2019 | Z-1775-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1777-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1774-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1773-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1776-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1772-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Oct 9, 2019 | Z-1778-2020 | — | terminated | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Aug 3, 2015 | Z-2761-2015 | — | terminated | Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. |