Natus Medical Incorporated FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx onlyClass IINov 28, 2023Sterility assurance cannot be guaranteed for external draina	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.	Class IIDevices	Nov 28, 2023
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx onlyClass IINov 28, 2023Sterility assurance cannot be guaranteed for external draina	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.	Class IIDevices	Nov 28, 2023
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set tClass IINov 18, 2022Due to Cranial Access Kits containing recalled sterile surgi	Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being	Class IIDevices	Nov 18, 2022