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U.S. Department of Health and Human Services

Class 2 Device Recall Embletta MPR PG

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 Class 2 Device Recall Embletta MPR PGsee related information
Date Initiated by FirmSeptember 29, 2026
Date PostedOctober 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0319-2027
Recall Event ID 99941
510(K)NumberK122516 
Product Classification Ventilatory effort recorder - Product Code MNR
ProductEmbletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
Code Information UDI-DI: 00382830023764; Serial Numbers: EBMPG-C1013678 EBMPG-C1013679 EBMPG-C1013682 EBMPG-C1013690 EBMPG-C1013691 EBMPG-C1013697 EBMPG-C1013700 EBMPG-C1013701 EBMPG-C1013703 EBMPG-C1013704 EBMPG-C1013707 EBMPG-C1013708 EBMPG-C1013748 EBMPG-C1013778 EBMPG-C1013779 EBMPG-C1013876 EBMPG-C1013566 EBMPG-C1013620 EBMPG-C1013632 EBMPG-C1013594 EBMPG-C1013596 EBMPG-C1013597 EBMPG-C1013599 EBMPG-C1013602 EBMPG-C1013614 EBMPG-C1013615 EBMPG-C1013617 EBMPG-C1013618 EBMPG-C1013414 EBMPG-C1013415 EBMPG-C1013416 EBMPG-C1013417 EBMPG-C1013448 EBMPG-C1013418 EBMPG-C1013591 EBMPG-C1013621 EBMPG-C1013629 EBMPG-C1013634 EBMPG-C1013636 EBMPG-C1013637 EBMPG-C1013643 EBMPG-C1013648 EBMPG-C1013655 EBMPG-C1013665 EBMPG-C1013609 EBMPG-C1013650 EBMPG-C1013652 EBMPG-C1013666 EBMPG-C1013670 EBMPG-C1013649 EBMPG-C1013293 EBMPG-C1013376 EBMPG-C1013387 EBMPG-C1013392 EBMPG-C1013398 EBMPG-C1013616 EBMPG-C1013633 EBMPG-C1013630 EBMPG-C1013638 EBMPG-C1013627 EBMPG-C1013541 EBMPG-C1013661 EBMPG-C1013667 EBMPG-C1013495 EBMPG-C1013572 EBMPG-C1013577 EBMPG-C1013578 EBMPG-C1013595 EBMPG-C1013610 EBMPG-C1013642 EBMPG-C1013653 EBMPG-C1013723 EBMPG-C1013734 EBMPG-C1013587 EBMPG-C1013590 EBMPG-C1013606 EBMPG-C1013611 EBMPG-C1013613 EBMPG-C1013641 EBMPG-C1013676 EBMPG-C1013542 EBMPG-C1013574 EBMPG-C1013583 EBMPG-C1013584 EBMPG-C1013672 EBMPG-C1013673 EBMPG-C1013680 EBMPG-C1013681 EBMPG-C1013683 EBMPG-C1013685 EBMPG-C1013686 EBMPG-C1013687 EBMPG-C1013688 EBMPG-C1013689 EBMPG-C1013693 EBMPG-C1013694 EBMPG-C1013695 EBMPG-C1013696 EBMPG-C1013706 EBMPG-C1013684 EBMPG-C1013698 EBMPG-C1013710 EBMPG-C1013712 EBMPG-C1013713 EBMPG-C1013714 EBMPG-C1013715 EBMPG-C1013716 EBMPG-C1013717 EBMPG-C1013718 EBMPG-C1013659 EBMPG-C1013728 EBMPG-C1013739 EBMPG-C1013426 EBMPG-C1013428 EBMPG-C1013429 EBMPG-C1013431 EBMPG-C1013442 EBMPG-C1013441 EBMPG-C1013607 EBMPG-C1013639 EBMPG-C1013646 EBMPG-C1013459 EBMPG-C1013467 EBMPG-C1013472 EBMPG-C1013476 EBMPG-C1013478 EBMPG-C1013612 EBMPG-C1013668 EBMPG-C1013635 EBMPG-C1013738 EBMPG-C1013731 EBMPG-C1013845 EBMPG-C1013422 EBMPG-C1013424 EBMPG-C1013434 EBMPG-C1013436 EBMPG-C1013437 EBMPG-C1013438 EBMPG-C1013447 EBMPG-C1013452 EBMPG-C1013453 EBMPG-C1013455 EBMPG-C1013460 EBMPG-C1013462 EBMPG-C1013464 EBMPG-C1013466 EBMPG-C1013471 EBMPG-C1013474 EBMPG-C1013475 EBMPG-C1013480 EBMPG-C1013482 EBMPG-C1013522 EBMPG-C1013586 EBMPG-C1013592 EBMPG-C1013579 EBMPG-C1013600 EBMPG-C1013619 EBMPG-C1013654 EBMPG-C1013598 EBMPG-C1013601 EBMPG-C1013603 EBMPG-C1013605 EBMPG-C1013721 EBMPG-C1013846 EBMPG-C1013465 EBMPG-C1013477 EBMPG-C1013479 EBMPG-C1013498 EBMPG-C1013504 EBMPG-C1013624 EBMPG-C1013737 EBMPG-C1013483 EBMPG-C1013484 EBMPG-C1013485 EBMPG-C1013486 EBMPG-C1013487 EBMPG-C1013488 EBMPG-C1013489 EBMPG-C1013490 EBMPG-C1013491 EBMPG-C1013492 EBMPG-C1013493 EBMPG-C1013494 EBMPG-C1013496 EBMPG-C1013499 EBMPG-C1013503 EBMPG-C1013543 EBMPG-C1013582 EBMPG-C1013581 EBMPG-C1013664 EBMPG-C1013608 EBMPG-C1013580 EBMPG-C1013724 EBMPG-C1013575 EBMPG-C1013589 EBMPG-C1013651 EBMPG-C1013726 EBMPG-C1013705 EBMPG-C1013456 EBMPG-C1013458 EBMPG-C1013468 EBMPG-C1013469 EBMPG-C1013473 EBMPG-C1013709 EBMPG-C1013481 EBMPG-C1013463 EBMPG-C1013720 EBMPG-C1013644 EBMPG-C1013625 EBMPG-C1013640 EBMPG-C1013675 EBMPG-C1013719 EBMPG-C1013732 EBMPG-C1013722 EBMPG-C1013735 EBMPG-C1013573 EBMPG-C1013576 EBMPG-C1013588 EBMPG-C1013593 EBMPG-C1013425 EBMPG-C1013427 EBMPG-C1013430 EBMPG-C1013432 EBMPG-C1013433 EBMPG-C1013444 EBMPG-C1013445 EBMPG-C1013423 EBMPG-C1013470 EBMPG-C1013505 EBMPG-C1013506 EBMPG-C1013507 EBMPG-C1013508 EBMPG-C1013509 EBMPG-C1013510 EBMPG-C1013511 EBMPG-C1013512 EBMPG-C1013513 EBMPG-C1013514 EBMPG-C1013515 EBMPG-C1013516 EBMPG-C1013517 EBMPG-C1013518 EBMPG-C1013519 EBMPG-C1013520 EBMPG-C1013521 EBMPG-C1013523 EBMPG-C1013538 EBMPG-C1013585 EBMPG-C1013440 EBMPG-C1013443 EBMPG-C1013656 EBMPG-C1013622 EBMPG-C1013725
FEI Number 3002809369
Recalling Firm/
Manufacturer		 NATUS MEDICAL INCORPORATED
2568 Bristol Cir
Oakville Canada
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component change control
ActionAn Urgent Medical Device Field Correction notification letter was sent to customers beginning 9/29/26. ACTION: " Review the serial numbers in this notice and identify any affected devices that are currently in your possession. " Immediately cease use of the affected product and quarantine until you receive further instructions from Natus for correcting the affected device(s). " Review all studies recorded on affected Embletta MPR devices to verify that patient information is correctly associated with the corresponding study and that the study data are complete, accurate, and attributable to the intended patient. " Please complete the enclosed form and return to FCA@Natus.com. If you have affected product, you will receive instructions on how to correct your affected Embletta MPR PG device(s) from FCA@Natus.com. All corrections will be provided at no cost to you. " If you do not have affected product, please respond to confirm no further actions are required. " Adverse reactions or quality problems experienced with the use of the part should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online at www.fda.gov/medwatch/report.htm. " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. RESOLUTION Investigation results have determined that the issue is caused by a recent change to the internal memory within the affected Embletta MPR devices. The corrective action is currently being finalized. Customers with affected devices should contact Natus using the information provided above. Natus will provide the necessary instructions to complete the corrective action. If you have any questions regarding this notice, please contact FCA@Natus.com.
Quantity in Commerce288 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, China, Italy, Portugal.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MNR
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