FDA recall, , Moderate risk
Natus Embletta MPR PG Sleep Monitor
The Embletta MPR PG Multi Parameter Recorder Sleep Monitor may be unable to correctly format its internal memory.
Summary by Recall Canary from the FDA notice
What happened
Natus Medical Incorporated of Oakville, Canada, voluntarily initiated a recall of the Embletta MPR PG Multi Parameter Recorder Sleep Monitor on September 29, 2026. The device may be unable to correctly format its internal memory, which can cause previously recorded studies to remain on the device and be updated with incorrect patient information from a subsequent study. The issue may also prevent studies from initiating recording successfully or may cause recordings to end prematurely.
The recall was added to the FDA's Enforcement Report and classified on October 30, 2026. The device was distributed worldwide, including the US nationwide and the countries of Canada, China, Italy, and Portugal. Customers were notified by letter.
The company initiated the recall voluntarily for 288 units.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Embletta MPR PG Multi Parameter Recorder Sleep Monitor
- Model number
- 2003011
- UDI-DI
- 00382830023764
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
US Nationwide and the countries of Canada, China, Italy, Portugal.
- Recalled by
- NATUS MEDICAL INCORPORATEDOakville, Canada
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99941
- Recall number
- Z-0319-2027
- Quantity recalled
- 288 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from NATUS MEDICAL INCORPORATED
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
NATUS MEDICAL began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
