RegWardenFDA facility compliance records
Recall

Class II — Curbell Medical, Inc.

Recalling firmCURBELL MEDICAL PRODUCTS, INC.
Registered facilityCURBELL MEDICAL PRODUCTS, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
ProductCURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
QuantityDomestic: 112 units; Foreign: 211 units
DistributionNationwide, Canada, Ireland, Italy
Initiated2014-08-05
Classified2014-08-26
Terminated2017-02-28
Recall numberZ-2554-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Curbell Medical, Inc. (Z-2554-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68961/

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