Drug & Device Safety Atlas
Class I FDA device recall · Z-2526-2023

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Why it was recalled

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
UDI: 07630002801850 & 07630002813532 / Affected Serial Numbers:    15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Distribution US nationwide, including Puerto Rico. OUS: Not provided

Recall record

Recalling firm
Hamilton Medical, Inc.
Product type
Devices
Recall number
Z-2526-2023
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Reno, NV
Recall initiated
2023-07-26

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2526-2023 · Source: openFDA enforcement.