Class II — Natus Medical Incorporated
| Recalling firm | Natus Medical Incorporated |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| Product | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only |
| Quantity | 2,686 units |
| Distribution | 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. |
| Initiated | 2023-11-28 |
| Classified | 2024-01-04 |
| Recall number | Z-0634-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Natus Medical Incorporated (Z-0634-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93550/
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