CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report

Ami HTX recalled by Spectral Instruments

Spectral Instruments is recalling Ami HTX. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers.

Quantity recalled35

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-2940-2026
FDA event ID: 99631
Recalling firm: Spectral Instruments, Tucson, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jul 2026
FDA classified: 4 Sep 2026
Reported: 26 Aug 2026
Type: FDA Mandated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jul 2026	Recall initiated by company
26 Aug 2026	Published in enforcement report	+33 days
4 Sep 2026	Classified by FDA	+9 days

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

Reason for recall

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Product as listed by the FDA

Ami HTX

Where it was distributed

United States.

Questions about this recall

Is Ami HTX recalled?

Yes. Spectral Instruments recalled Ami HTX on 24 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2940-2026.

Why was it recalled?

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Which lots are affected?

All serial numbers.

Where was it sold?

United States.

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 21 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 Spectral Instruments

All 4

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Lago X recalled by Spectral Instruments	Spectral Instruments	Other	AZ
25 Jun 2025Device	CLASS II	Lago X recalled by Spectral Instruments	Spectral Instruments	Other	AZ
25 Jun 2025Device	CLASS II	Ami HTX recalled by Spectral Instruments	Spectral Instruments	Other	AZ

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide