Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER…
Medical device recall Z-0661-2025. Published in FDA’s Enforcement Report on Dec 25, 2024.
- FDA Class I
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 Dec 25, 2024. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 65,810 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
65,810 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number and Description: 24146 EDMS 24146 BECKER NO Y-SITE UDI-DI/GTIN code: 00763000333423 Lot Numbers: 219712762 220791262 220836565 222082056 226933414 227950454 25120 EDMS II 25120 BECKER W/1-WAY VALVE UDI-DI/GTIN code:…
Every code shown here, 1,988 characters
Product Number and Description: 24146 EDMS 24146 BECKER NO Y-SITE UDI-DI/GTIN code: 00763000333423 Lot Numbers: 219712762 220791262 220836565 222082056 226933414 227950454 25120 EDMS II 25120 BECKER W/1-WAY VALVE UDI-DI/GTIN code: 00763000333430 Lot Numbers: 219712914 219890583 219912494 220051377 220490117 221213296 221343122 221482483 222322808 222559082 222810773 223580281 223580282 223580283 225234349 226072076 226810273 227906031 228957822 229230810 UDI-DI/GTIN code: 00763000431297 Lot Number: 228080125 26040 KIT 26040 BECKER EDMS II UDI-DI/GTIN code: 00763000333447 Lot Numbers: 219694908 219728986 219744900 219798954 220018272 220051379 220158549 220158894 220171612 220198300 220458253 220490118 220522916 220564314 220564315 220564316 220651436 220791263 220836806 220883511 220968714 221131925 221158918 221189857 221213294 221303411 221528223 221687661 221743772 221795482 221873433 222620587 222620588 222620589 222658552 222695494 222817388 222817390 222887926 222999289 222999291 222999293 223621049 223621051 223659549 223659552 223659555 223697541 223778300 224032598 224173188 224277829 224387150 224387152 224387154 224437365 224438287 224471872 224471874 224643554 225375789 225727017 226072074 226072077 226090342 226090345 226111240 226111242 226111244 226111268 226150981 226151064 226241860 226288867 226335055 226951038 227188110 227446479 227446507 227490159 227538045 227539127 227585327 227634613 227634615 227666438 227668740 227668742 227735796 227735798 227779089 227862470 227906042 227951886 228841691 228858954 228858956 228858958 228858960 228913261 228914143 229049637 229049643 229100505 229101087 229101091 229101093 229239419 229391821 229542957 UDI-DI/GTIN code: 00763000406066 Lot Numbers: 228027884 228081252 228123193 228123195 228260082 228260606 228287013 228287015 228312659 228312661 228326183 228357011 228357013 228402670 228450311 228450313 228499617 228499618 228783157 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE UDI-DI/GTIN code:…
FDA’s list runs to 6,378 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 nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
The states and territories these words name
- Puerto Rico
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 Nov 1, 2024.
- FDA classified it on Dec 19, 2024.
- FDA’s Enforcement Report published it on Dec 25, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neurosurgery, of Fort Worth, TX.
- 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 6,378 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.