Curbell Medical Recalls CareSense Bed and Chair Monitors
Curbell Medical is recalling CareSense Wireless Advanced LCD Bed and Chair Monitors because a circuit board modification disabled the alarm function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a safety-critical alarm function has failed, creating a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Curbell Medical, Inc. is recalling the CareSense Wireless Advanced LCD Bed and Chair Monitor, Model # CSM-BC400. This device is a bed patient monitor connected to a sensor pad that sounds an alarm if a patient attempts to arise from a bed, chair, floor mat, or toilet seat.
The recall was initiated after a customer complaint revealed that a resistor was incorrectly placed on the monitor's circuit board. This modification was a planned change intended to improve battery drain, but it resulted in the monitor's alarm via the nurse call communication port failing to function.
The recall affects 112 domestic units and 211 foreign units distributed nationwide, as well as in Canada, Ireland, and Italy. The affected units are identified by Lot 0414. Consumers and healthcare facilities should stop using the affected monitors and contact Curbell Medical, Inc. for instructions on how to proceed.
The recalled product
- Product
- CURBELL 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…
- Manufacturer
- Curbell Medical, Inc.
- Category
- Medical Device — Patient Monitor
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 0414
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- HighSpacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection
FDA (Devices) · 2012-07-25
- HighSpacelabs qube Patient Monitor Recalled for Power-On Failure
FDA (Devices) · 2013-11-27
- HighOridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall
FDA (Devices) · 2018-10-10
- HighGE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
FDA (Devices) · 2014-03-19
- HighGE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss
FDA (Devices) · 2014-07-30
- HighHill-Rom Centrella Smart+ Bed Recall for Alert System Failure
FDA (Devices) · 2020-06-10