In the agency's Nov 11, 2026 enforcement report · Ongoing
Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
Natus Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NATUS MEDICAL INCORPORATED · 2568 Bristol Cir · Oakville
Is this the product you have?
- Embletta MPR PG Multi Parameter Recorder Sleep Monitor
- Model/Catalog Number2003011
- Lot codes and dates
- UDI-DI00382830023764
- Serial Numbers
253 of 253 codes
EBMPG-C1013678EBMPG-C1013679EBMPG-C1013682EBMPG-C1013690EBMPG-C1013691EBMPG-C1013697EBMPG-C1013700EBMPG-C1013701EBMPG-C1013703EBMPG-C1013704EBMPG-C1013707EBMPG-C1013708EBMPG-C1013748EBMPG-C1013778EBMPG-C1013779EBMPG-C1013876EBMPG-C1013566EBMPG-C1013620EBMPG-C1013632EBMPG-C1013594EBMPG-C1013596EBMPG-C1013597EBMPG-C1013599EBMPG-C1013602EBMPG-C1013614EBMPG-C1013615EBMPG-C1013617EBMPG-C1013618EBMPG-C1013414EBMPG-C1013415EBMPG-C1013416EBMPG-C1013417EBMPG-C1013448EBMPG-C1013418EBMPG-C1013591EBMPG-C1013621EBMPG-C1013629EBMPG-C1013634EBMPG-C1013636EBMPG-C1013637EBMPG-C1013643EBMPG-C1013648EBMPG-C1013655EBMPG-C1013665EBMPG-C1013609EBMPG-C1013650EBMPG-C1013652EBMPG-C1013666EBMPG-C1013670EBMPG-C1013649EBMPG-C1013293EBMPG-C1013376EBMPG-C1013387EBMPG-C1013392EBMPG-C1013398EBMPG-C1013616EBMPG-C1013633EBMPG-C1013630EBMPG-C1013638EBMPG-C1013627
- Amount recalled
- 288 units
Where it was sold
- Nationwide
Why it was recalled
The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may 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, resulting in incomplete or unavailable diagnostic data and the potential need to repeat a patient study.
This product could cause temporary or reversible health problems — stop using it.
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