Hamilton Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2528-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Product Classification:

Class I

Date Initiated: July 26, 2023
Date Posted: September 27, 2023
Recall Number: Z-2528-2023
Event ID: 92873
Reason for Recall:

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.

Status: Ongoing
Product Quantity: 12 units
Code Information:

UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated