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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95725

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 01, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Medtronic Neurosurgery

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-0661-2025
Recall number
Z-0661-2025
Initiated
November 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
65,810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Code information

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: 00763000333485 Lot Numbers: 219712763 220400528 222082057 226998769 227862472 UDI-DI/GTIN code: 00763000529307 Lot Number: 228230540 27670 BECKER 27670 STOP BELOW DC NDL-LS IN UDI-DI/GTIN code: 00763000333522 Lot Numbers: 219712765 219887171 220651439 222049071 224032600 224643848 226182608 226490977 229010912 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN UDI-DI/GTIN code: 00763000333539 Lot Number: 222258694 27702 EDMS 27702 EURO BECKER II GR PT LN UDI-DI/GTIN code: 00763000333553 Lot Numbers: 219887172 220749000 222049069 223697544 224032601 224438305 225375792 225630424 226288866 227585329 227779107 228081264 228913264 229101096 UDI-DI/GTIN code: 00763000467326 Lot Number: 228260612 27761 BECKER 27761 STOP BCNDLESS PATLN 24 UDI-DI/GTIN code: 00763000333577 Lot Numbers: 219887170 220610533 222049070 225198001 226616230 227762295 229393847 27767 BECKER 27767 NO STPCOCK ON PTLN 63 UDI-DI/GTIN code: 00763000333584 Lot Numbers: 219968507 227539144 27779 EDMS 27779 BECKER BC NDLESS BOND CONN UDI-DI/GTIN code: 00763000333591 Lot Numbers: 219712764 219807627 220400529 220461637 223088136 223255544 225198002 226150985 226366029 227467158 227467159 227585567 228123250 228670577 228670578 228670579 228670580 228734465 228783163 UDI-DI/GTIN code: 00763000529345 Lot Numbers: 228179777 228230535 228230536 228260080 228260081 228287012 228312658 228402669 228535135 27811 EDMS 27811 BECKER GRN PL VCATH UDI-DI/GTIN code: 00763000333638 Lot Number: 221343633 27931 EDMS 27931 BECKER GS TUBING SMARTSITES UDI-DI/GTIN code: 00763000333669 Lot Numbers: 219912495 220462686 220763088 221795484 221853177 223270455 224032607 224438289 225234324 225270200 225422436 226180686 226616219 226951446 227188115 227779111 227906188 227906189 46128 EDMS 46128 BECKER II BLUE PT LN UDI-DI/GTIN code: 00763000333676 Lot Numbers: 219603333 219603334 219603335 219642506 219653249 219653255 219656940 219738928 219744775 219798953 219839808 219926903 219988065 219988526 220018274 220522915 220610535 220610536 220677063 220749002 220752016 220836810 220837993 220883519 220935479 220935480 220935481 220952094 220968715 220968724 221091163 221103633 221131924 221262027 221303407 221343621 221343622 221343623 221419373 221419374 221419375 221482530 221579110 221579111 221613870 221614449 221648849 221687761 221744152 221795485 221828781 221873435 222015659 222015660 222049066 222082055 222121356 222218166 222218167 222240778 222240779 222240780 222322809 222322810 222345100 222345101 222413277 222413278 222481090 222523762 222523763 222523765 222530276 222530277 222530278 222581026 222633228 223088137 223088138 223270456 223270457 224032602 224032603 224032604 224032605 224032606 224083875 224083876 224128117 224128509 224173193 224438304 224471685 224515872 224559928 224593528 224643565 224643846 225198808 225198809 225234352 225234353 225279754 225279755 225336438 225336439 225422437 225630425 225675931 225726235 225726236 225726237 225749476 225749477 225795544 225795545 225804025 225804706 225804707 225805226 226420553 226420554 226616231 226616232 226616233 226896331 226896332 226896335 226933415 226933422 226933423 226951447 227446514 227446518 227490161 227490162 227539129 227585330 227585331 227634660 227634661 227669625 227735837 227779113 227862484 227862485 227862506 227906190 227951892 227951893 228000489 228000490 228000491 228620727 228620728 228783449 228783450 228783452 228841696 228859329 UDI-DI/GTIN code: 00763000406073 Lot Numbers: 227906191 228012564 228012565 228029450 228081277 228123253 228123254 228123255 228230537 228230538 228260610 228312663 228312664 228357016 228388891 228388892 228388893 228422468 228422469 228422470 228422472 228422473 228499619 228499620 228512025 228514226 228536235 228579130 228693165 228693406 228693407 228693409 228714965 46129 EDMS 46129 EURO BECKER II BLUE PT LN UDI-DI/GTIN code: 00763000333683 Lot Numbers: 219656939 219744779 219807231 219839809 220018276 220118014 220120890 220120892 220651438 220791265 220791528 220836811 221262143 221262144 221419372 221648850 221796467 222015662 224515873 224643847 225279756 225375791 226072079 226616234 226951448 227446522 227490164 227539130 227585332 227634662 227669626 227735838 227779114 228629471 228914030 228914031 229142581 UDI_DI/GTIN code: 00763000431259 Lot Numbers: 228012786 228029451 228029452 228123256 228260611 228287017 228287018 228311925 228312665

Distribution pattern

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.

device · product 2 of 2

Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).

Z-0662-2025
Recall number
Z-0662-2025
Initiated
November 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
258,367 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Code information

Product Number and Description: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM UDI-DI/GTIN code: 00763000333478 Lot Numbers: 219434737 219792667 220703679 221213992 221262137 221368619 221482482 221744146 222163800 224643556 225336427 225727016 226111266 226490968 227188117 227332070 227669616 227762294 228914035 228957823 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK UDI-DI/GTIN code: 00763000333492 Lot Numbers: 219390373 219631712 219792681 219888963 220475062 220522923 221159131 221262142 221525913 221744147 222083286 222277590 222658559 223027467 223165952 223300957 224083868 224289845 224438296 225279638 225336428 226111267 226366019 226490969 227188114 227332071 227951891 228081263 228579143 228783458 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN UDI-DI/GTIN code: 00763000333515 Lot Numbers: 219390375 219603331 219792673 220100028 220236200 220236201 220286893 220288205 220293731 220295164 220295420 220295421 220315153 220315154 221133364 221303416 221687758 221860411 222083287 222163798 222204316 222658830 222810946 223027466 223052246 223070520 223070521 223165951 223255543 224083873 224083874 224342648 224593537 225234323 225631426 226111270 226111271 226366028 226516611 226516612 226516613 227136783 227381120 227381121 227634653 227669617 227735833 227779106 228230541 228858404 228858405 228957825 229010910 229101095 229189950 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP UDI-DI/GTIN code: 00763000333560 Lot Numbers: 219888964 220197686 220703680 221059818 221068867 221068879 221213993 221744148 228230542 228501266 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ UDI-DI/GTIN code: 00763000333607 Lot Numbers: 219390374 219603332 219792676 220249832 220258472 220258473 221159127 221303417 221687759 222163799 224515878 224643553 225198003 225675933 225795996 226366027 227136784 227634657 228081271 229010916 27795 EDMS 27795 EXACTA 100ML CATH UDI-DI/GTIN code: 00763000333614 Lot Numbers: 219694828 221482480 221922072 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL UDI-DI/GTIN code: 00763000333645 Lot Numbers: 221687760 227188116 227906187 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE UDI-DI/GTIN code: 00763000333690 Lot Numbers: 219317961 219317962 219317963 219317964 219317965 219318226 219318227 219318228 219318229 219351420 219351421 219351422 219351423 219351424 219351425 219352386 219390368 219390369 219390370 219390371 219434735 219434736 219434738 219434739 219434740 219434741 219434742 219434743 219434744 219434745 219435376 219481332 219481359 219481379 219481420 219481443 219481461 219511967 219512845 219513667 219513669 219513670 219528348 219528351 219528353 219543686 219543714 219603043 219603044 219603045 219603327 219603329 219656942 219656943 219656944 219656945 219683574 219683575 219738003 219738930 219742408 219792669 219836483 219837605 219838586 219838587 219838588 219838589 219854730 219854733 219890567 219890568 220105879 220105880 220156494 220156495 220156496 220156497 220171611 220198178 220198179 220279972 220282626 220288204 220295416 220295417 220295418 220313865 220315146 220315147 220315148 220445512 220455469 220522924 220527536 220610537 220610538 220651432 220651433 220703684 220703685 220749667 220749668 220791470 220791471 220836817 220836818 220836928 220883515 220883516 220935797 220935798 220935827 220952095 220964564 220968719 220968720 221034568 221034569 221092006 221099016 221133365 221159141 221213991 221262141 221482531 221526852 221526853 221528497 221569958 221569959 221598133 221598134 221604937 221614446 221614447 221614448 221646710 221648851 221652156 221687227 221687228 221687229 221744155 221777133 221777135 221777136 221796470 221826632 221827836 221873441 221874035 221916510 221916666 221916667 221955180 221955181 221955182 221955183 221955184 221955185 221955226 222083288 222088592 222121365 222125827 222125828 222125829 222141577 222152806 222163790 222163791 222163792 222163793 222163794 222163795 222163796 222163797 222204311 222204312 222204313 222204314 222204315 222240774 222295173 222464026 222584505 222586146 222595117 222595118 222595119 222595343 222595344 222620332 222620333 222620334 222620335 222620336 222658562 222658563 222658564 222658565 222658826 222658827 222658828 222695526 222695527 222695528 222695529 222695530 222695531 222724794 222724795 222724796 222724797 222724798 222724799 222724800 222724801 222724802 222724803 222737818 222737819 222741347 222741348 222741349 222741350 222742110 222742111 222742112 222742113 222742114 222742115 222742116 222742117 222742118 222810782 222810783 222810784 222844866 222844867 222989540 222989541 222998499 223027468 223027469 223027470 223044800 223070522 223070523 223070524 223070525 223130633 223130634 223130635 223130636 223130637 223130638 223130639 223165955 223165956 223165957 223165958 223214640 223214641 223214642 223214643 223234778 223234779 223255545 223300955 223343108 223343109 223428532 223468525 223469126 223469127 223469128 223514992 223514993 223514994 223514995 223580353 223580354 223580355 223580356 223580357 223621053 223621054 223683435 223697538 223697539 223734518 224128510 224128511 224173194 224213956 224213957 224213958 224213959 224219819 224279370 224342649 224342650 224342651 224342652 224342653 224342654 224342655 224403023 224411011 224438299 224438300 224515874 224515875 224515876 224559935 224559936 224559937 224559938 224559939 224559940 224559941 224559942 224593529 224593530 224593531 224593532 224593533 224593534 224593535 224593536 224643563 224643564 224643849 224643850 224649357 224649358 224686692 225198810 225198811 225198812 225198813 225234325 225234346 225271658 225271659 225271660 225336429 225336430 225336432 225367587 225367588 225367589 225375165 225375793 225412012 225412013 225507891 225507892 225507893 225507894 225507895 225631427 225631428 225665228 225665229 225665230 225665231 225665232 225665233 225675935 225675936 225675937 225675938 225723853 225723854 225723855 225723856 225723857 225723858 225726232 225726233 225727008 225727009 225727010 225727011 225727013 225793239 225793240 225793241 225795529 225795530 225795531 225837235 225837236 225837237 225837238 225872251 225872252 225872253 225872254 225881267 225889903 225933616 225933617 225933618 225965217 226060358 226060360 226060361 226060362 226060363 226150983 226150984 226191061 226191062 226191063 226191064 226191065 226241854 226241857 226288877 226288878 226288879 226314384 226314385 226316226 226316227 226335050 226335051 226335052 226335053 226335054 226366014 226366015 226366016 226420557 226420558 226490970 226490971 226490972 226516619 226516620 226516621 226516622 226516623 226516624 226516625 226517886 226567473 226567474 226567475 226567476 226567477 226567478 226567479 226567480 226567481 226567482 226567483 226727118 226727119 226727121 226727122 226727123 226727124 226728006 226756267 226756268 226756269 226914771 226914772 226914773 226914774 226914775 226914776 226914777 226914778 226914779 226951449 226951450 226951451 226951452 226951453 226951454 226951455 226951457 226951458 227006505 227031534 227136785 227137126 227137127 227137128 227137129 227137130 227137131 227137132 227137133 227137134 227137135 227137136 227191620 227191621 227191622 227191623 227235963 227235964 227235965 227236806 227236807 227236808 227236809 227236810 227236811 227236812 227272902 227272903 227272904 227272905 227273146 227273147 227273148 227273149 227273150 227273151 227307877 227307878 227307879 227307880 227332072 227332073 227332074 227332075 227332076 227332077 227332078 227332079 227332080 227332081 227381162 227381163 227381164 227381165 227381166 227381167 227381168 227381169 227420329 227420330 227420331 227420332 227420333 227420334 227420335 227420336 227420337 227420338 227420339 227420340 227420342 227490165 227490786 227490787 227490788 227490790 227490792 227491070 227539131 227539132 227539134 227539135 227539136 227585333 227585334 227585335 227634691 227634692 227634693 227669627 227669628 227669629 227689639 227689641 227689642 227697014 227697015 227697016 227697017 227843358 227843359 227843360 227843361 227862507 227862508 227862509 227906192 227951894 227951895 227951896 227951897 227951898 227951899 227951900 228029455 228029456 228081280 228081281 228081282 228081283 228123257 228123258 228123260 228123261 228180045 228192554 228192555 228230689 228260619 228260620 228287025 228287306 228287307 228314366 228314367 228314368 228314369 228314370 228357021 228357022 228357023 228358146 228402746 228402747 228450321 228450322 228450323 228450324 228501267 228579145 228579226 228579227 228611718 228611719 228611720 228643680 228643681 228643682 228670569 228670571 228670572 228670684 228670686 228670687 228670688 228700237 228718675 228718676 228718677 228718678 228718679 228718680 228718683 228718684 228718685 228737493 228737494 228783460 228783462 228783463 228783464 228858946 228858947 228858948 228858949 228858950 228858951 228858952 228859334 228859335 228859336 228859337 228914036 228914037 228914038 228914039 228914040 228914041 228914042 228914043 228914044 228957881 228957883 228957884 228957885 228957886 228957887 229010921 229010922 229010923 229049855 229049856 229049857 229049858 229049859 229101102 229101103 229101104 229101105 229101106 229101107 229101108 229127589 229127592 229142583 229142584 229142585 229143306 229190409 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML UDI-DI/GTIN code: 00763000333706 Lot Numbers: 219390372 219395752 220051766 220156498 220236202 220244366 220453468 220461215 221158924 221262136 221525914 221827837 221916511 221916669 221922073 221952419 221952420 221955178 222277588 222277589 222595124 222595125 222601683 222629818 222658829 222695532 222724804 222742119 222810785 223130640 223165959 223833463 223833464 223833727 223878399 224277484 224277485 224277826 224277827 224303369 224303370 224303371 224303372 224342502 224438297 224438298 224471869 224471870 224515879 225198814 225198815 225234347 225234348 225271661 225271662 225336433 225336434 225375786 225375787 225412024 225422434 225422435 225631429 225675934 225726234 225727012 225727014 225727015 225837239 225837240 225885117 225885118 225885119 226366017 226366018 227137137 227137138 227194733 227194734 227307881 227307882 227307883 227307884 227307885 227420343 227490793 227585336 227585337 227726341 227726342 227726343 227726344 227779119 227843362 228081284 228123262

Distribution pattern

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.