{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Middleton", "address_1": "3150 Pleasant View Rd", "reason_for_recall": "Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the user\u0019s ability to clearly hear heart rate and/or blood flow.", "address_2": "", "product_quantity": "2,335 units total", "code_info": "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 CBQ0637 CBQ0638 CBQ0639 CBQ0640 CBQ0641 CBQ0642 CBQ0643 CBQ0644 CBQ0645 CBQ0646 CBQ0647 CBQ0648 CBQ0649 CBQ0650 CBQ0651 CBQ0652 CBQ0653 CBQ0654 CBQ0655 CBQ0656 CBQ0657 CBQ0658 CBQ0659 CBQ0660 CBQ0661 CBQ0662 CBQ0663 CBQ0664 CBQ0665 CBQ0666 CBQ0667 CBQ0668 CBQ0669 CBQ0670 CBQ0671 CBQ0672 CBQ0673 CBQ0674 CBQ0675 CBQ0676 CBQ0677 CBQ0678 CBQ0679 CBQ0680 CBQ0681 CBQ0682 CBQ0683 CBQ0684 CBQ0685 CBQ0686 CBQ0687 CBQ0688 CBQ0689 CBQ0690 CBQ0691 CBQ0692 CBQ0693 CBQ0694 CBQ0695 CBQ0696 CBQ0697 CBQ0698 CBQ0699 CBR0100 CBR0101 CBR0102 CBR0103 CBR0104 CBR0105 CBR0106 CBR0107 CBR0108 CBR0109 CBR0110 CBR0111 CBR0112 CBR0113 CBR0114 CBR0115 CBR0116 CBR0117 CBR0118 CBR0119 CBR0120 CBR0121 CBR0122 CBR0123 CBR0124 CBR0125 CBR0126 CBR0127 CBR0128 CBR0129 CBR0130 CBR0131 CBR0132 CBR0133 CBR0134 CBR0135 CBR0136 CBR0137 CBR0138 CBR0139 CBR0140 CBR0141 CBR0142 CBR0143 CBR0144 CBR0145 CBR0146 CBR0147 CBR0148 CBR0149 CBR0150 CBR0151 CBR0152 CBR0153 CBR0154 CBR0155 CBR0156 CBR0157 CBR0158 CBR0159 CBR0160 CBR0161 CBR0162 CBR0163 CBR0164 CBR0165 CBR0166 CBR0167 CBR0168 CBR0169 CBR0170 CBR0171 CBR0172 CBR0173 CBR0174 CBR0175 CBR0176 CBR0177 CBR0178 CBR0179 CBR0180 CBR0181 CBR0182 CBR0183 CBR0184 CBR0185 CBR0186 CBR0187 CBR0188 CBR0189 CBR0190 CBR0191 CBR0192 CBR0193 CBR0194 CBR0195 CBR0196 CBR0197 CBR0198 CBR0199 CBR0200 CBR0201 CBR0202 CBR0203 CBR0204 CBR0205 CBR0206 CBR0207 CBR0208 CBR0209 CBR0210 CBR0211 CBR0212 CBR0213 CBR0214 CBR0215 CBR0216 CBR0217 CBR0218 CBR0219 CBR0220 CBR0221 CBR0222 CBR0223 CBR0224 CBR0225 CBR0226 CBR0227 CBR0228 CBR0229 CBR0230 CBR0231 CBR0232 CBR0233 CBR0234 CBR0235 CBR0236 CBR0237 CBR0238 CBR0239 CBR0240 CBR0241 CBR0242 CBR0243 CBR0244 CBR0245 CBR0246 CBR0247 CBR0248 CBR0249 CBR0250 CBR0251 CBR0252 CBR0253 CBR0254 CBR0255 CBR0256 CBR0257 CBR0258 CBR0259 CBR0260 CBR0261 CBR0262 CBR0263 CBR0264 CBR0265 CBR0266 CBR0267 CBR0268 CBR0269 CBR0270 CBR0271 CBR0272 CBR0273 CBR0274 CBR0275 CBR0276 CBR0277 CBR0278 CBR0279 CBR0280 CBR0281 CBR0282 CBR0283 CBR0284 CBR0285 CBR0286 CBR0287 CBR0288 CBR0289 CBR0290 CBR0291 CBR0292 CBR0293 CBR0294 CBR0295 CBR0296 CBR0297 CBR0298 CBR0299 CBR0300 CBR0301 CBR0302 CBR0303 CBR0304 CBR0305 CBR0306 CBR0307 CBR0308 CBR0309 CBR0311 CBR0312 CBR0313 CBR0314, and CBR0315.", "center_classification_date": "20170713", "distribution_pattern": "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.", "state": "WI", "product_description": "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.", "report_date": "20170719", "classification": "Class II", "openfda": {}, "recalling_firm": "Natus Neurology Inc", "recall_number": "Z-2729-2017", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "77569", "termination_date": "20200722", "more_code_info": "", "recall_initiation_date": "20170609", "postal_code": "53562-4800", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }