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myCordella Patient App
Endotronix, Inc. · Model 100256-02 · UDI-DI 00850008997037
0
510(k) clearances
1,609
Adverse events (17 deaths)
232
Recalls
60
Facilities
Description
myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Cardinal Health 200, LLC | Kits contain infusion sets which were recalled for performance issues. |
| 2026-09-02 | Medline Industries, LP | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin |
| 2026-08-11 | Medline Industries, LP | The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | American Contract Systems Inc | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-07-29 | Cardinal Health 200, LLC | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is |
| 2026-07-20 | Medline Industries, LP | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.