Nicolet¿ Elite¿ 3 MHz OB Probe
Medical device recall Z-2728-2017. 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¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. 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: CAQ0100 CAQ0101 CAQ0102 CAQ0103 CAQ0104 CAQ0105 CAQ0106 CAQ0107 CAQ0108 CAQ0109 CAQ0110 CAQ0111 CAQ0112 CAQ0113 CAQ0114 CAQ0115 CAQ0116 CAQ0117 CAQ0118 CAQ0119 CAQ0120 CAQ0121 CAQ0122 CAQ0123 CAQ0124 CAQ0125 CAQ0126 CAQ0127…
Every code shown here, 2,000 characters
Serial numbers: CAQ0100 CAQ0101 CAQ0102 CAQ0103 CAQ0104 CAQ0105 CAQ0106 CAQ0107 CAQ0108 CAQ0109 CAQ0110 CAQ0111 CAQ0112 CAQ0113 CAQ0114 CAQ0115 CAQ0116 CAQ0117 CAQ0118 CAQ0119 CAQ0120 CAQ0121 CAQ0122 CAQ0123 CAQ0124 CAQ0125 CAQ0126 CAQ0127 CAQ0128 CAQ0129 CAQ0130 CAQ0131 CAQ0132 CAQ0133 CAQ0134 CAQ0135 CAQ0136 CAQ0137 CAQ0138 CAQ0139 CAQ0140 CAQ0141 CAQ0142 CAQ0143 CAQ0144 CAQ0145 CAQ0146 CAQ0147 CAQ0148 CAQ0149 CAQ0150 CAQ0151 CAQ0152 CAQ0153 CAQ0154 CAQ0155 CAQ0156 CAQ0157 CAQ0158 CAQ0159 CAQ0160 CAQ0161 CAQ0162 CAQ0163 CAQ0164 CAQ0165 CAQ0166 CAQ0167 CAQ0168 CAQ0169 CAQ0170 CAQ0171 CAQ0172 CAQ0173 CAQ0174 CAQ0175 CAQ0176 CAQ0177 CAQ0178 CAQ0179 CAQ0180 CAQ0181 CAQ0182 CAQ0183 CAQ0184 CAQ0185 CAQ0186 CAQ0187 CAQ0188 CAQ0189 CAQ0190 CAQ0191 CAQ0192 CAQ0193 CAQ0194 CAQ0195 CAQ0196 CAQ0197 CAQ0198 CAQ0199 CAQ0200 CAQ0201 CAQ0202 CAQ0203 CAQ0204 CAQ0205 CAQ0206 CAQ0207 CAQ0208 CAQ0209 CAQ0210 CAQ0211 CAQ0212 CAQ0213 CAQ0214 CAQ0215 CAQ0216 CAQ0217 CAQ0218 CAQ0219 CAQ0220 CAQ0221 CAQ0222 CAQ0223 CAQ0224 CAQ0225 CAQ0226 CAQ0227 CAQ0228 CAQ0229 CAQ0230 CAQ0231 CAQ0232 CAQ0233 CAQ0234 CAQ0235 CAQ0236 CAQ0237 CAQ0238 CAQ0239 CAQ0240 CAQ0241 CAQ0242 CAQ0243 CAQ0244 CAQ0245 CAQ0246 CAQ0247 CAQ0248 CAQ0249 CAQ0250 CAQ0251 CAQ0252 CAQ0253 CAQ0254 CAQ0255 CAQ0256 CAQ0257 CAQ0258 CAQ0259 CAQ0260 CAQ0261 CAQ0262 CAQ0263 CAQ0264 CAQ0265 CAQ0266 CAQ0267 CAQ0268 CAQ0269 CAQ0270 CAQ0271 CAQ0272 CAQ0273 CAQ0274 CAQ0275 CAQ0276 CAQ0277 CAQ0278 CAQ0279 CAQ0280 CAQ0281 CAQ0282 CAQ0283 CAQ0284 CAQ0285 CAQ0286 CAQ0287 CAQ0288 CAQ0289 CAQ0290 CAQ0291 CAQ0292 CAQ0293 CAQ0294 CAQ0295 CAQ0296 CAQ0297 CAQ0298 CAQ0299 CAQ0300 CAQ0301 CAQ0302 CAQ0303 CAQ0304 CAQ0305 CAQ0306 CAQ0307 CAQ0308 CAQ0309 CAQ0310 CAQ0311 CAQ0312 CAQ0313 CAQ0314 CAQ0315 CAQ0316 CAQ0317 CAQ0318 CAQ0319 CAQ0320 CAQ0321 CAQ0322 CAQ0323 CAQ0324 CAQ0325 CAQ0326 CAQ0327 CAQ0328 CAQ0329 CAQ0330 CAQ0331 CAQ0332 CAQ0333 CAQ0334 CAQ0335 CAQ0336 CAQ0337 CAQ0338 CAQ0339 CAQ0340 CAQ0341 CAQ0342 CAQ0343 CAQ0344 CAQ0345 CAQ0346 CAQ0347…
FDA’s list runs to 13,685 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 13,685 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
-
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.