Nicolet¿ Elite¿ 5 MHz Vascular Probe
Medical device recall Z-2729-2017. Published in FDA’s Enforcement Report on Jul 19, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 19, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 44 states named in where it went
- 2,335 units total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
2,335 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: CBQ0302 CBQ0344 CBQ0385 CBQ0386 CBQ0387 CBQ0388 CBQ0389 CBQ0390 CBQ0391 CBQ0392 CBQ0393 CBQ0394 CBQ0395 CBQ0396 CBQ0397 CBQ0398 CBQ0399 CBQ0400 CBQ0401 CBQ0402 CBQ0403 CBQ0404 CBQ0410 CBQ0411 CBQ0412 CBQ0413 CBQ0414 CBQ0415…
Every code shown here, 2,000 characters
Serial numbers: CBQ0302 CBQ0344 CBQ0385 CBQ0386 CBQ0387 CBQ0388 CBQ0389 CBQ0390 CBQ0391 CBQ0392 CBQ0393 CBQ0394 CBQ0395 CBQ0396 CBQ0397 CBQ0398 CBQ0399 CBQ0400 CBQ0401 CBQ0402 CBQ0403 CBQ0404 CBQ0410 CBQ0411 CBQ0412 CBQ0413 CBQ0414 CBQ0415 CBQ0416 CBQ0417 CBQ0418 CBQ0419 CBQ0420 CBQ0421 CBQ0422 CBQ0423 CBQ0424 CBQ0425 CBQ0426 CBQ0427 CBQ0428 CBQ0429 CBQ0430 CBQ0431 CBQ0432 CBQ0433 CBQ0434 CBQ0435 CBQ0436 CBQ0437 CBQ0438 CBQ0439 CBQ0440 CBQ0441 CBQ0442 CBQ0443 CBQ0444 CBQ0445 CBQ0446 CBQ0447 CBQ0448 CBQ0449 CBQ0450 CBQ0451 CBQ0452 CBQ0453 CBQ0454 CBQ0455 CBQ0456 CBQ0457 CBQ0458 CBQ0459 CBQ0460 CBQ0461 CBQ0462 CBQ0463 CBQ0464 CBQ0465 CBQ0466 CBQ0467 CBQ0468 CBQ0469 CBQ0470 CBQ0471 CBQ0472 CBQ0473 CBQ0474 CBQ0475 CBQ0476 CBQ0477 CBQ0478 CBQ0479 CBQ0480 CBQ0481 CBQ0482 CBQ0483 CBQ0484 CBQ0485 CBQ0486 CBQ0487 CBQ0488 CBQ0489 CBQ0490 CBQ0491 CBQ0492 CBQ0493 CBQ0494 CBQ0495 CBQ0496 CBQ0497 CBQ0498 CBQ0499 CBQ0500 CBQ0501 CBQ0502 CBQ0503 CBQ0504 CBQ0505 CBQ0506 CBQ0507 CBQ0508 CBQ0509 CBQ0510 CBQ0511 CBQ0512 CBQ0513 CBQ0514 CBQ0515 CBQ0516 CBQ0517 CBQ0518 CBQ0519 CBQ0520 CBQ0521 CBQ0522 CBQ0523 CBQ0524 CBQ0525 CBQ0526 CBQ0527 CBQ0528 CBQ0529 CBQ0530 CBQ0531 CBQ0532 CBQ0533 CBQ0534 CBQ0535 CBQ0536 CBQ0537 CBQ0538 CBQ0539 CBQ0540 CBQ0541 CBQ0542 CBQ0543 CBQ0544 CBQ0545 CBQ0546 CBQ0547 CBQ0548 CBQ0549 CBQ0550 CBQ0551 CBQ0552 CBQ0553 CBQ0554 CBQ0555 CBQ0556 CBQ0557 CBQ0558 CBQ0559 CBQ0560 CBQ0561 CBQ0562 CBQ0563 CBQ0564 CBQ0565 CBQ0566 CBQ0567 CBQ0568 CBQ0569 CBQ0570 CBQ0571 CBQ0572 CBQ0573 CBQ0574 CBQ0575 CBQ0576 CBQ0577 CBQ0578 CBQ0579 CBQ0580 CBQ0581 CBQ0582 CBQ0583 CBQ0584 CBQ0585 CBQ0586 CBQ0587 CBQ0588 CBQ0589 CBQ0590 CBQ0591 CBQ0592 CBQ0593 CBQ0594 CBQ0595 CBQ0596 CBQ0597 CBQ0598 CBQ0599 CBQ0600 CBQ0601 CBQ0602 CBQ0603 CBQ0604 CBQ0605 CBQ0606 CBQ0607 CBQ0608 CBQ0609 CBQ0610 CBQ0611 CBQ0612 CBQ0613 CBQ0614 CBQ0615 CBQ0616 CBQ0617 CBQ0618 CBQ0619 CBQ0620 CBQ0621 CBQ0622 CBQ0623 CBQ0624 CBQ0625 CBQ0626 CBQ0627 CBQ0628 CBQ0629 CBQ0630 CBQ0631 CBQ0633 CBQ0634 CBQ0635 CBQ0636…
FDA’s list runs to 4,229 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and, to the countries of Australia, Canada, Chile, Columbia, Germany, India, Japan, Jordan, Kuwait, Netherlands, Papua Guinea, Philippines, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, and United Kingdom.
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 9, 2017.
- FDA classified it on Jul 13, 2017.
- FDA’s Enforcement Report published it on Jul 19, 2017.
- FDA terminated it on Jul 22, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Natus Neurology Inc, of Middleton, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,229 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.