FDA Medical devices recall ·
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0661-2025
- Date
- (initiated November 1, 2024)
- Company / brand
- Medtronic Neurosurgery
4620 North Beach Street, Fort Worth, TX, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 65,810 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
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.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0661-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.