Each number has its full source under its own list below.
Device recalls
52 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Automated External Defibrillators (Non-Wearable)
Reason: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Automated External Defibrillators (Non-Wearable)
Reason: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Automated External Defibrillators (Non-Wearable)
Reason: Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform…
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Automated External Defibrillators (Non-Wearable)
Reason: Due to pediatric defibrillator electrode delamination
Automated External Defibrillators (Non-Wearable)
Reason: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Automated External Defibrillators (Non-Wearable)
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Automated External Defibrillators (Non-Wearable)
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Automated External Defibrillators (Non-Wearable)
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Automated External Defibrillators (Non-Wearable)
Reason: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
510(k) clearances
61 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Wearable Breast Pump (model S36)
Company: Shenzhen TPH Technology Co., Ltd.
Wearable Ecg Recorder (ymheart Xy-12); Wearable Ecg Recorder (ymheart Xy-1201); Wearable Ecg Recorder (ymheart Xy-1202); Wearable Ecg Recorder (ymheart Xy-1203…
Company: Shenzhen Xinyan Medical Technology Co.,ltd.
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (model: Scf593/52, Scf593/62); Philips Avent Natural Care Warming Hands-free Wearable Elect…
Company: Philips Consumer Lifestyle B.V.
Wearable Breast Pump (model: Xn/md-2249bs, Zfhf)
Company: Guangdong Horigen Mother & Baby Products Co., Ltd.
Wearable Electric Breast Pump (ym-8837, Ym-8838, Ym-8856(h03), Ym-8809(s42))
Company: Guangdong Youmeng Electrical Technology Co., Ltd.
Discreetduo Flow Wearable Breast Pump (model S3)
Company: Shenzhen TPH Technology Co., Ltd.
Wearable Breast Pump (model S32a)
Company: Shenzhen TPH Technology Co., Ltd.
Wearable Breast Pump (qy-101, Qy-102, Qy-108)
Company: Shenzhen Qinyi Electronic Technology Co., Ltd.
Momcozy Wearable Breast Pump (bp311, Bp311-a, Bp311-b, Bp311-c, Bp311-d)
Company: Shenzhen Root Innovation Technology Co., Ltd.
Momcozy Wearable Breast Pump (bp420, Bp420-a, Bp420-b, Bp420-c, Bp420-d )
Company: Shenzhen Root Innovation Technology Co., Ltd.
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
Market reports on remote monitoring and wearables
Aging in Place Technology
Worldwide · 2024–2034
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View report Medical DevicesAutomated Insulin Delivery Systems
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View report Medical DevicesBiosensors
Worldwide · 2024–2034
View report Medical DevicesCardiac Monitoring Wearables
Worldwide · 2024–2034
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Acuitas market sizes and forecasts are only in our full reports. How we use public data.