Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734…
Medical device recall Z-1241-2022. Published in FDA’s Enforcement Report on Jun 15, 2022.
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 Jun 15, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 106,033 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?
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520
106,033, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 14445809 NS14440413 14438720 NS14533529 NS14531987 NS14512935 NS14531991 NS14531985 NS14531989 NS14531990 NS14531993 NS14531994 14230667 14219518 14228061 14232591 14233388 14233393 14280197 14299971 14239561 14239563 14240096…
Every code shown here, 1,995 characters
Lots: 14445809 NS14440413 14438720 NS14533529 NS14531987 NS14512935 NS14531991 NS14531985 NS14531989 NS14531990 NS14531993 NS14531994 14230667 14219518 14228061 14232591 14233388 14233393 14280197 14299971 14239561 14239563 14240096 14227837 14231033 14231052 14232846 14318778 14343805 NS14318613 NS14345341 14325852 14366728 NS14341560 NS14345338 NS14345796 14317075 14366729 14395251 14446172 14452759 14461634 14542803 14542804 14542805 NS14533531 14502814 14233390 14223991 14280196 14299968 14299969 14228357 14240093 14240095 14240097 14242960 14280193 14280194 NS14242956 NS14267436 NS14285103 NS14285105 NS14285113 NS14285116 NS14285118 14343806 14343808 14401670 14560261 14242333 14242961 14244909 14230666 14231051 14231480 14236762 14239564 14240094 14242899 14280195 14244951 14340480 14343008 14363296 NS14329321 14363792 14371377 14392159 14557484 14558691 14560262 14244907 14239562 14303167 14303168 14233392 14244908 14387092 14391580 14368792 14394030 14404724 14411527 14411533 NS14393837 14392161 14310711 14392479 NS14401834 14393836 14394139 14407670 NS14411530 14392162 14395248 14395250 14401669 14404664 14458554 14469137 14461546 14557483 14560260 14568246 14324499 14324561 14329743 NS14357214 14368791 14405012 14404722 14407669 14407731 14444295 14445814 14459064 14239565 14248731 14270214 14230668 14231034 14232592 14299970 NS14280198 14343807 14329319 14363297 14329744 14329746 14356323 NS14354206 NS14356996 NS14356998 NS14357000 NS14357208 NS14357211 14329738 14334099 NS14458938 14458553 14438764 14459660 14460713 NS14445808 14117167 NS14204660 NS14204661 14264718 14317112 14322914 14314095 14354105 14354308 NS14345792 NS14354207 NS14356995 NS14357209 NS14357216 14331801 14345342 14395165 14329353 14461977 14461477 14461828 14427826 14443855 14461633 14464822 14492202 14493151 14493152 14248725 14248726 14259109 14264230 14261712 14275595 14341563 NS14357210 14329745 14333908 14396081 14399139 14338855 14343042 14345340 14329742 14438721 14450442…
FDA’s list runs to 37,661 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.
Domestic distribution nationwide. Foreign distribution worldwide.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 May 5, 2022.
- FDA classified it on Jun 6, 2022.
- FDA’s Enforcement Report published it on Jun 15, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Incorporated, of Bloomington, IN.
- 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 37,661 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.