Home › Endotronix, Inc. › myCordella Patient Kit

myCordella Patient Kit

Endotronix, Inc. · Model 100171-00 · UDI-DI 00850008997068

OEZ

510(k) clearances

1,350

Adverse events (17 deaths)

225

Recalls

Facilities

Description

myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to doctors • Provides secure communication between patient and doctor • Provides access to patient education materials • Facilitates review of past measurements • Facilitates review of patient goals myCordella Peripherals Medical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.

Recalls

Date	Firm	Reason
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
2026-07-29	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
2026-07-14	Cardinal Health 200, LLC	Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-10	Medline Industries, LP	Kits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-29	American Contract Systems Inc	The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ
2026-06-29	American Contract Systems Inc	The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ
2026-06-29	American Contract Systems Inc	The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ
2026-06-29	American Contract Systems Inc	The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ
2026-06-12	Medline Industries, LP	The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.