CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report
Moberg Component Neuromonitoring System recalled by Moberg Research
Moberg Research is recalling Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term, distributed nationwide in the US. The recall was initiated on 20 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1338-2023
- FDA event ID
- 91782
- Recalling firm
- Moberg Research, Ambler, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2023
- FDA classified
- 4 Apr 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Patient Monitors
Timeline
| 20 Feb 2023 | Recall initiated by company | |
| 4 Apr 2023 | Classified by FDA | +43 days |
| 12 Apr 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
Where it was distributed
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
Questions about this recall
Is Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term recalled?
Yes. Moberg Research recalled Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term on 20 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1338-2023.
Why was it recalled?
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
Which lots are affected?
UDI Number: B485CNS3501 Serial Numbers: A-CNS-22502 A-CNS-22506 A-CNS-22507 A-CNS-22508 A-CNS-22509 A-CNS-22510 A-CNS-22511 A-CNS-22512 A-CNS-22513 A-CNS-22525 A-CNS-22526 A-CNS-22527 A-CNS-22528 A-CNS-22529 A-CNS-22530 A-CNS-22534 A-CNS-22535 A-CNS-22536 A-CNS-22537 A-CNS-22541 A-CNS-22542 A-CNS-22543 A-CNS-22544 A-CNS-22545 A-CNS-22546 A-CNS-22547 A-CNS-22548 A-CNS-22549 A-CNS-22550 A-CNS-22551 A-CNS-22552 A-CNS-22553 A-CNS-22554 A-CNS-22555 A-CNS-22556 A-CNS-22557 A-CNS-22558 A-CNS-22559 A-CNS-22560 A-CNS-22561 A-CNS-22562 A-CNS-22564 A-CNS-22565 A-CNS-22566 A-CNS-22567 A-CNS-22568 A-CNS-22569 A-CNS-22570 A-CNS-22571 A-CNS-22572 A-CNS-22573 A-CNS-22574 A-CNS-22575 A-CNS-22577 A-CNS-22578 A-CNS-22584 A-CNS-22585 A-CNS-22586 A-CNS-22587 A-CNS-22588 A-CNS-22589 A-CNS-22590 A-CNS-22591
Where was it sold?
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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