CLASS II ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report
Ami HTX recalled by Spectral Instruments
Spectral Instruments is recalling Ami HTX. The recall was initiated on 13 May 2025 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-1942-2025
- FDA event ID
- 97035
- Recalling firm
- Spectral Instruments, Tucson, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2025
- FDA classified
- 18 Jun 2025
- Reported
- 25 Jun 2025
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 May 2025 | Recall initiated by company | |
| 18 Jun 2025 | Classified by FDA | +36 days |
| 25 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Product as listed by the FDA
Ami HTX.
Where it was distributed
US
Questions about this recall
Why was it recalled?
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Which lots are affected?
Accession number 2510780-000
Where was it sold?
US
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
1 other product · FDA event 97035| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
More recalls from Spectral Instruments
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ami HTX recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
| Device | CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
| Device | CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
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