Spectral Instruments recall: Lago X and 1 more product
Spectral Instruments Inc is recalling Lago X and 1 more product – 40; 35. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 24, 2026. Distributed United States..
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Share
| Product | Lago X and 1 more product |
| Brand | Spectral Instruments |
| Company | Spectral Instruments Inc |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 24, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 40; 35 |
| Recall ID | 99631 |
Recalled products (2)
- Lago X
- FDA recall number
- Z-2939-2026
- Codes, lots and dates
- All serial numbers.
- Quantity
- 40
- Classification
- Class II
- Ami HTX
- FDA recall number
- Z-2940-2026
- Codes, lots and dates
- All serial numbers.
- Quantity
- 35
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99631
- Initiated
- FDA Mandated
- Status
- Ongoing
- Firm location
- Tucson, AZ, United States
Why it was recalled
The reason the FDA lists: “Momentary absence of On-Screen "X-Ray On" banner during run readiness check.”
Where it was sold
Distribution as the FDA records it: “United States.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99631, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I | |
| Oct 7, 2026 | a fire hazard Most serious | FDA Class I | |
| Oct 7, 2026 | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II | |
| Oct 7, 2026 | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II | |
| Oct 7, 2026 | The potential for falsely elevated results. Serious | FDA Class II | |
| Oct 7, 2026 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Spectral Instruments Lago X recalled?
Yes. Spectral Instruments Inc recalled it on July 24, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
United States..
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.