CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Infant Flow Sensor, single use, (3.1m) recalled by Hamilton Medical

Hamilton Medical is recalling Infant Flow Sensor, single use, (3.1m), distributed nationwide in the US. The recall was initiated on 1 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPN 260179, all lot codes.

Quantity recalled154 total, all part numbers

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-1965-2015
FDA event ID: 71434
Recalling firm: Hamilton Medical, Reno, NV
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2015
FDA classified: 2 Jul 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: CPAP & Ventilators

Timeline

1 Jun 2015	Recall initiated by company
2 Jul 2015	Classified by FDA	+31 days
8 Jul 2015	Published in enforcement report	+6 days

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

Reason for recall

An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.

Product as listed by the FDA

Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

PN 260179, all lot codes.

Where was it sold?

US Nationwide Distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

2 other products · FDA event 71434

This product is part of a recall event; the main page for the event is Infant Flow Sensor, single use, (1.6m) recalled by Hamilton Medical.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2015	CLASS II	Infant Flow Sensor, single use, (1.6m) recalled by Hamilton Medical	Hamilton Medical	Labeling Errors	Nationwide
8 Jul 2015	CLASS II	Infant Flow Sensor, single use, (1.88m) recalled by Hamilton Medical	Hamilton Medical	Labeling Errors	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