CLASS I ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part recalled

Hamilton Medical is recalling Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for, distributed nationwide in the US. The recall was initiated on 26 Jul 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669

Quantity recalled4 shielding set

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2530-2023
FDA event ID: 92873
Recalling firm: Hamilton Medical, Reno, NV
Classification: Class I
Status: Ongoing
Recall initiated: 26 Jul 2023
FDA classified: 20 Sep 2023
Reported: 27 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: CPAP & Ventilators

Timeline

26 Jul 2023	Recall initiated by company
20 Sep 2023	Classified by FDA	+56 days
27 Sep 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 92873

This product is part of a recall event; the main page for the event is Hamilton C1/T1/MR1 recalled by Hamilton Medical.

Reported	Class	Recall	Company	Reason	Where
27 Sep 2023	CLASS I	Hamilton C1/T1/MR1 recalled by Hamilton Medical	Hamilton Medical	Packaging Defects	Nationwide
27 Sep 2023	CLASS I	Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recalled	Hamilton Medical	Packaging Defects	Nationwide
27 Sep 2023	CLASS I	Hamilton-MR1, REF: 161010, Intensive Care Ventilator recalled	Hamilton Medical	Packaging Defects	Nationwide
27 Sep 2023	CLASS I	Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recalled	Hamilton Medical	Packaging Defects	Nationwide
27 Sep 2023	CLASS I	Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recalled	Hamilton Medical	Packaging Defects	Nationwide

More recalls from Hamilton Medical

All 34

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	IntelliCuff, Portable automatic cuff pressure controller recalled	Hamilton Medical	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS I	Hamilton C6 recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS I	Breathing circuit set, coaxial, 1.80 m, with flow sensor recalled	Hamilton Medical	Device Malfunction	Nationwide
26 Jun 2024Device	CLASS I	Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

All 554

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide