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Fisher and Paykel Healthcare is recalling thousands of breathing devices around the world because of potentially faulty alarms.
The company said alarms on its Airvo-2 and myAirvo-2 humidifiers made before 14 August 2017 may not work properly in alerting a user to falling oxygen levels.
"The voluntary limited recall relates to a speaker configuration issue that may result in distorted, intermittent or inaudible alarm sound levels. This does not affect the therapy delivered by the Airvo 2 or myAirvo 2 device and the devices will otherwise perform as intended.
"The Airvo 2 and myAirvo 2 devices are not intended for life support and appropriate patient monitoring is required at all times. If there is an interruption to therapy a patient may experience oxygen desaturation."
Fisher and Paykel said the models were superseded in late 2017, but there was an estimated 9000 still in use.
It said it was contacting hospitals, dealers and distributors to replace the devices.
The recall is estimated to cost around $12 million, which was not allowed for in a recent earnings update.
The company also noted that recent tax changes removing the depreciation allowance on commercial buildings will hit its tax bill this year, although it could not say by how much.
Shares in F&P Healthcare, the highest value stock on the NZX, fell 61 cents or 2.3 percent to $25.81 in early trading.