FDA Device Intelligence
Home › MUNCHKIN, INC. › The Medicator

The Medicator

MUNCHKIN, INC. · Model 12501 · UDI-DI 00735282125010

KYW
2
510(k) clearances
209
Adverse events
13
Recalls
215
Facilities

Description

Safe, easy, and accurate way to dispense liquid medicine Medicine bypasses baby's taste buds reducing gagging and spitting up

Recalls

DateFirmReason
2025-10-14Becton Dickinson & CompanyBD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
2024-05-09Sol-Millennium Medical Inc.Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
2022-07-04Medicina Uk LtdPlunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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 keyRead 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.