Medix NatalCare ST-LX Intensive Care Incubator — Class II medical device recall Z-1363-2016
Terminated recall by Natus Medical Incorporated, reported 2016-04-20, distributed nationwide. NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the
| Recall number | Z-1363-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2016-01-08 |
| Classified | 2016-04-11 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | PK |
| Reason classes | device malfunction |
| Serial numbers | 5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213 and 50 more |
Product
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1363-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.