Hamilton Medical Intellicuff Standalone: Motor may stop working during use
Hamilton Medical recalls Intellicuff Standalone (PN 951:1000-2090) due to risk of motor failure during use. This device measures and maintains cuff pressure for ventilated patients. Affected units may stop functioning, requiring immediate action.
Use caution until it’s fixed
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Contact the company
What happened, in plain English
Hamilton Medical is recalling Intellicuff Standalone devices (serial numbers 1000-2090) because the motor may stop working during use. This could lead to improper cuff pressure maintenance for ventilated patients, potentially causing harm. Read more at govinfonow.com/recall/73823-hamilton-medical-intellicuff-standalone-motor-may-stop-working-during-use.
Source Summary by GovInfoNow · govinfonow.com/recall/73823-hamilton-medical-intellicuff-standalone-motor-may-stop-working-during-use · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0335-2018
Cite this page
“Hamilton Medical Intellicuff Standalone: Motor may stop working during use.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73823-hamilton-medical-intellicuff-standalone-motor-may-stop-working-during-use. Based on FDA recall #Z-0335-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0335-2018%22&limit=1).
Why it’s dangerous
The motor in the Intellicuff Standalone may stop working during use, which could cause the device to fail in maintaining proper cuff pressure. This might lead to inadequate ventilation or other complications for patients who rely on the device.
Who’s affected
Healthcare providers using the Intellicuff Standalone for mechanical ventilation of patients in hospitals or clinics. Patients receiving ventilatory support are at risk if the device stops functioning.
How to tell if you have this one
Check for serial numbers 1000 through 2090 on the Intellicuff Standalone device. The product is used to measure and maintain cuff pressure for ventilated patients.
- Brand
Hamilton Medical- Category
Medical device
What to do — step by step
Check Device Function
Ensure the motor is operating normally before use. If it stops working, stop using the device immediately.
Where it went and when
Where it was distributed
Distributed in Illinois and Texas.
FDA distribution: “US Distribution to IL and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Texas.
Recall timeline
FDA published this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0335-2018 (June 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0335-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.