Natus Medical Recalls Medix NatalCare ST-LX Neonatal Incubators
Natus Medical is recalling Medix NatalCare ST-LX neonatal incubators because defective hinge assemblies may cause ports to detach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (neonatal incubator) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Natus Medical Incorporated is recalling Medix NatalCare ST-LX Intensive Care Incubators. The recall involves 75 units, with 65 units distributed in the United States and 10 units in Pakistan. The final status report updated the count to 36 customers with 96 units.
The recall was initiated because the incubators were manufactured with a defective oval port hinge assembly. This defect can cause the screws holding the port in place to become loose, potentially resulting in the port detaching from the incubator.
The affected units are distributed nationwide in the United States and in Pakistan. Specific serial numbers are listed in the official recall documentation. Consumers and healthcare facilities should check their inventory against the provided serial number list and contact Natus Medical for instructions on corrective actions.
The recalled product
- Product
- Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
- Manufacturer
- Natus Medical Incorporated
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: 5337
- 5336
- 5335
- 5334
- 5333
- 5332
- 5331
- 5330
- 5329
- 5328
- 5327
- 5326
- 5325
- 5324
- 5323
- 5294
- 5293
- 5292
- 5291
- 5290
Distribution
Distributed nationwide across the United States.
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