CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Arial Water Resistant Pendant with Long Wristband recalled
Securitas Healthcare is recalling Arial Water Resistant Pendant with Long Wristband, distributed nationwide in the US. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0222-2024
- FDA event ID
- 93188
- Recalling firm
- Securitas Healthcare, Lincoln, NE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2023
- FDA classified
- 3 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2023 | Recall initiated by company | |
| 3 Nov 2023 | Classified by FDA | +39 days |
| 15 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Which lots are affected?
Manufacturing date codes: 23128 to 23251
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93188| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Arial Water Resistant Pendant with Wristband recalled | Securitas Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Arial Water Resistant Pendant with Neck Lanyard recalled | Securitas Healthcare | Device Malfunction | Nationwide |
More recalls from Securitas Healthcare
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Arial 900 MHz Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Server recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 13 states |
| Device | CLASS II | Arial Call Station recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | 9 states |
| Device | CLASS II | Arial mobile application recalled by Securitas Healthcare | Securitas Healthcare | Device Malfunction | Nationwide |
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