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 | Terminated |
| Reason | NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator. |
| Product | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. |
| Quantity | 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units. |
| Distribution | Distribution US nationwide and Pakistan. |
| Initiated | 2016-01-08 |
| Classified | 2016-04-11 |
| Terminated | 2017-02-10 |
| Recall number | Z-1363-2016 |
| 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-1363-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72894/
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