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Mui Scientific
H & A Mui Enterprises Inc · Model C7-PR-1054 · UDI-DI 00678467006240
1
510(k) clearances
417
Adverse events
7
Recalls
31
Facilities
Description
Customized Reusable Pediatric Anorectal 8 Channel Catheter (with Balloon)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Laborie Medical Technologies Corp | Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the h |
| 2026-05-13 | Covidien, LLC | Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures. |
| 2025-06-04 | Diversatek Healthcare | Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels |
| 2023-07-25 | Diversatek Healthcare | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| 2011-10-12 | Sierra Scientific Instruments Inc | The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Fi |
| 2009-02-23 | Sandhill Scientific, Inc | Software error may produce incorrect esophageal contraction readings. |
| 2004-04-28 | Medtronic Gastroenterology / Urology | Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short. |
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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.