Embryology Heated Plate within the RI Witness
Medical device recall Z-0029-2020. Published in FDA’s Enforcement Report on Oct 9, 2019.
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 Oct 9, 2019. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 10 states named
- 60 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The touchpad may not work properly after cleaning.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.
60, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0006 0051 0097 0146 0192 0244 0292 0354 0420 0487 0617 0672 0732 0783 0007 0052 0098 0147 0193 0245 0293 0356 0421 0489 0618 0673 0733 0784 0008 0053 0100 0148 0194 0246 0294 0357 0424 0490 0619 0674 0734 0785 0009 0054…
Every code shown here, 1,996 characters
Serial Numbers: 0006 0051 0097 0146 0192 0244 0292 0354 0420 0487 0617 0672 0732 0783 0007 0052 0098 0147 0193 0245 0293 0356 0421 0489 0618 0673 0733 0784 0008 0053 0100 0148 0194 0246 0294 0357 0424 0490 0619 0674 0734 0785 0009 0054 0101 0149 0195 0247 0297 0358 0426 0491 0622 0675 0735 0786 0010 0055 0102 0150 0196 0248 0298 0359 0428 0492 0628 0676 0736 0787 0011 0056 0103 0151 0197 0249 0299 0360 0429 0493 0630 0677 0738 0788 0012 0057 0104 0152 0198 0250 0300 0361 0430 0494 0631 0678 0739 0789 0013 0058 0105 0153 0199 0251 0302 0362 0431 0495 0632 0679 0740 0790 0014 0060 0106 0154 0200 0252 0303 0364 0432 0496 0633 0680 0741 0791 0015 0061 0107 0155 0201 0253 0304 0366 0433 0497 0634 0681 0742 0792 0016 0062 0108 0156 0203 0254 0306 0367 0434 0498 0635 0682 0743 0793 0017 0063 0109 0157 0204 0255 0307 0368 0435 0499 0636 0683 0744 0794 0018 0064 0110 0158 0205 0256 0308 0369 0438 0501 0637 0684 0745 0795 0019 0065 0111 0159 0206 0257 0309 0370 0440 0502 0638 0685 0747 0796 0020 0066 0112 0160 0207 0258 0311 0371 0441 0503 0639 0686 0748 0797 0021 0067 0113 0161 0208 0259 0312 0372 0442 0504 0641 0687 0749 0798 0022 0068 0114 0162 0209 0260 0313 0373 0443 0505 0642 0688 0752 0799 0023 0069 0115 0163 0210 0261 0314 0374 0444 0508 0643 0689 0753 0800 0024 0070 0116 0164 0211 0263 0315 0375 0445 0509 0644 0690 0754 0801 0025 0071 0117 0165 0212 0264 0316 0378 0446 0511 0645 0691 0755 0802 0026 0072 0118 0166 0213 0265 0317 0380 0447 0512 0646 0703 0756 0803 0027 0073 0119 0167 0214 0266 0318 0381 0449 0513 0647 0704 0757 0028 0074 0120 0168 0215 0267 0319 0383 0450 0514 0648 0705 0758 0029 0075 0121 0169 0216 0268 0320 0386 0453 0515 0649 0707 0759 0030 0076 0122 0170 0217 0269 0321 0388 0455 0516 0650 0708 0760 0031 0077 0123 0171 0218 0270 0322 0389 0456 0520 0651 0709 0761 0032 0078 0124 0173 0219 0271 0323 0390 0457 0528 0653 0710 0762 0033 0079 0125 0174 0220 0272 0324 0393 0458 0530 0654 0712 0763 0034 0080 0126 0175 0221 0273 0325 0394 0459 0600 0655…
FDA’s list runs to 3,045 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 - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ, PA, & WA, and countries of Canada and Denmark.
The states and territories these words name
- California
- Colorado
- Connecticut
- Georgia
- Illinois
- Michigan
- North Carolina
- New Jersey
- Pennsylvania
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Sep 5, 2019.
- FDA classified it on Oct 2, 2019.
- FDA’s Enforcement Report published it on Oct 9, 2019.
- FDA terminated it on Sep 2, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CooperSurgical, Inc., of Trumbull, CT.
- 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 3,045 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.