Hamilton Medical IntelliCuff Device Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Hamilton Medical AG is recalling 962 IntelliCuff portable automatic cuff pressure controllers due to potential "Cuff System Leakage" errors.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Hamilton Medical AG initiated a recall of the IntelliCuff device after reports that it may trigger a "Cuff System Leakage" error alarm. This can cause the motor to pump continuously and prevent the device from maintaining the user-set cuff pressure.
Which Products Are Affected
The recall covers the IntelliCuff, Portable automatic cuff pressure controller, REF: 951001. GTIN: 07630002800839. Lot numbers range from 00001 to 19732. A total of 962 units are affected. Distribution includes the United States (AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY) and Canada.
What You Should Do
No specific consumer instructions are provided in the recall notice.
Why This Matters
The Class II recall affects devices used to control cuff pressure, with potential for continuous motor operation and failure to maintain set pressure.
Source
FDA recall Z-2625-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (961 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.