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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

Class I recall

FDA calls the CooperSurgical INCA infant CPAP recall Class I over cannula connections that work loose

MedDevice Startups Staff · 2 days ago · 2 min read · Via FDA

FDA classified CooperSurgical's removal of INCA infant nasal CPAP sets as Class I on September 18 and refreshed the notice on September 21. The flexible tubing can loosen where it joins the nasal cannula, which drops delivered pressure and oxygen to newborns and infants.

CooperSurgical wrote to customers on August 11 and FDA posted an early alert on August 24. Nine part numbers are covered across multiple lot codes: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715, 44-0712, 44-0707, 44-0709 and 44-0715. No injuries or deaths had been reported as of the August 11 letter. The event ID is 99643.

The company is telling hospitals to stop using affected sets, quarantine stock and return it, and to substitute other tubing or CPAP equipment if a connection feels loose in use. A joint that passes bench pull testing and then backs off in a NICU is the failure mode design verification tends to miss.

Questions & Answers

Why did CooperSurgical recall the INCA infant nasal CPAP sets?

The flexible tubing can develop a loose connection where it joins the nasal cannula. That causes pressure loss and reduced oxygen delivery to newborns and infants.

Is the CooperSurgical INCA CPAP recall a Class I recall?

Yes. FDA classified it Class I, its most serious category, on September 18, 2026, after posting an early alert on August 24, 2026.

Were any injuries reported with the CooperSurgical INCA nasal CPAP sets?

No injuries or deaths had been reported as of CooperSurgical's August 11, 2026 customer letter.

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