CLASS II Device recall · Reported 6 Nov 2024 · FDA Enforcement Report

AVOXimeter 1000E, Product Number: AVOX1000E recalled

Accriva Diagnostics is recalling AVOXimeter 1000E, Product Number: AVOX1000E, distributed in Arizona. The recall was initiated on 27 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10711234530023. Serial Number: 6824

Quantity recalled1

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-0279-2025
FDA event ID: 95497
Recalling firm: Accriva Diagnostics, San Diego, CA
Classification: Class II
Status: Completed
Recall initiated: 27 Sep 2024
FDA classified: 31 Oct 2024
Reported: 6 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

27 Sep 2024	Recall initiated by company
31 Oct 2024	Classified by FDA	+34 days
6 Nov 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

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

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

Where it was distributed

US: AZ

Arizona

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 10711234530023. Serial Number: 6824

Where was it sold?

US: AZ

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.

More recalls from Accriva Diagnostics

All 6

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	directCHECK Act-lr whole blood quality control, level recalled	Accriva Diagnostics	Potency & Assay	Nationwide
10 Dec 2025Device	CLASS II	Hemochron Activated Clotting Time Low-Range Test Cuvette recalled	Accriva Diagnostics	Foreign Material	Nationwide
19 Nov 2025Device	CLASS III	VerifyNow PRUTest Platelet Reactivity Test recalled	Accriva Diagnostics	Packaging Defects	Nationwide
22 Jan 2025Device	CLASS II	VerifyNow P2Y12 Platelet Reactivity Test recalled by Accriva Diagnostics	Accriva Diagnostics	Other	Nationwide
1 Jun 2022Device	CLASS II	The VerifyNow P2Y12 Test is designed to measure platelet recalled	Accriva Diagnostics	Particulate Matter	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide