Natus Medical Incorporated: Medical Device Recall in 2024 - (Recall #: Z-0634-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Product Classification:

Class II

Date Initiated: November 28, 2023

Date Posted: January 10, 2024

Recall Number: Z-0634-2024

Event ID: 93550

Reason for Recall:

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Status: Ongoing

Product Quantity: 2,686 units

Code Information:

UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455

Distribution Pattern:

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.

Voluntary or Mandated:

Voluntary: Firm initiated