Class 2 Device Recall RENASYS EDGE

• Date Initiated by Firm: October 02, 2024
• Date Posted: November 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0516-2025
• Recall Event ID: 95558
• 510(K)Number: K223041
• Product Classification: negative pressure wound therapy Powered suction pump - Product Code OMP
• Product: RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
• Code Information: Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ230515 PEAB230036 PEAE230440 PEAF230211 PEAG230288 PEAH230221 PEAH230877 PEAJ230525 PEAB230037 PEAE230441 PEAF230212 PEAG230289 PEAH230222 PEAH230879 PEAJ230526 PEAB230039 PEAE230442 PEAF230217 PEAG230292 PEAH230223 PEAH230882 PEAJ230527 PEAB230041 PEAE230443 PEAF230221 PEAG230294 PEAH230224 PEAH230883 PEAJ230530 PEAB230042 PEAE230448 PEAF230222 PEAG230295 PEAH230225 PEAH230884 PEAJ230532 PEAB230044 PEAE230450 PEAF230226 PEAG230301 PEAH230226 PEAH230885 PEAJ230538 PEAB230048 PEAE230452 PEAF230233 PEAG230303 PEAH230227 PEAH230886 PEAJ230541 PEAB230050 PEAE230454 PEAF230236 PEAG230305 PEAH230228 PEAH230888 PEAJ230542 PEAB230051 PEAE230455 PEAF230237 PEAG230306 PEAH230229 PEAH230889 PEAJ230545 PEAB230052 PEAE230456 PEAF230239 PEAG230307 PEAH230230 PEAH230892 PEAJ230558 PEAB230053 PEAE230458 PEAF230243 PEAG230308 PEAH230231 PEAH230893 PEAJ230563 PEAB230054 PEAE230459 PEAF230247 PEAG230309 PEAH230234 PEAH230896 PEAJ230564 PEAB230057 PEAE230461 PEAF230249 PEAG230313 PEAH230235 PEAH230897 PEAJ230565 PEAB230059 PEAE230462 PEAF230250 PEAG230315 PEAH230237 PEAH230899 PEAJ230578 PEAB230060 PEAE230463 PEAF230254 PEAG230322 PEAH230239 PEAH230903 PEAJ230580 PEAB230061 PEAE230464 PEAF230255 PEAG230326 PEAH230240 PEAH230904 PEAJ230588 PEAB230063 PEAE230466 PEAF230258 PEAG230327 PEAH230241 PEAH230905 PEAJ230591 PEAB230064 PEAE230467 PEAF230267 PEAG230329 PEAH230243 PEAH230906 PEAJ230604 PEAB230065 PEAE230468 PEAF230269 PEAG230335 PEAH230244 PEAH230907 PEAJ230605 PEAB230066 PEAE230470 PEAF230273 PEAG230337 PEAH230245 PEAH230908 PEAJ230610 PEAB230069 PEAE230471 PEAF230277 PEAG230340 PEAH230246 PEAH230909 PEAJ230611 PEAB230070 PEAE230473 PEAF230280 PEAG230342 PEAH230248 PEAH230911 PEAJ230613 PEAB230072 PEAE230474 PEAF230281 PEAG230344 PEAH230249 PEAH230912 PEAJ230614 PEAB230074 PEAE230476 PEAF230284 PEAG230346 PEAH230250 PEAH230914 PEAJ230615 PEAB230080 PEAE230480 PEAF230285 PEAG230347 PEAH230252 PEAH230915 PEAJ230619 PEAB230080 PEAE230481 PEAF230287 PEAG230348 PEAH230253 PEAH230916 PEAJ230620 PEAC230081 PEAE230483 PEAF230288 PEAG230349 PEAH230256 PEAH230917 PEAJ230622 PEAC230083 PEAE230484 PEAF230289 PEAG230350 PEAH230258 PEAH230918 PEAJ230628 PEAC230087 PEAE230487 PEAF230290 PEAG230351 PEAH230259 PEAH230922 PEAJ230630 PEAC230088 PEAE230489 PEAF230291 PEAG230353 PEAH230260 PEAH230923 PEAJ230634 PEAC230089 PEAE230491 PEAF230292 PEAG230354 PEAH230262 PEAH230925 PEAJ230642 PEAC230090 PEAE230493 PEAF230293 PEAG230355 PEAH230263 PEAH230927 PEAJ230643 PEAC230091 PEAE230494 PEAF230294 PEAG230357 PEAH230264 PEAH230928 PEAJ230645 PEAC230092 PEAE230496 PEAF230295 PEAG230358 PEAH230265 PEAH230930 PEAJ230646 PEAC230093 PEAE230498 PEAF230296 PEAG230359 PEAH230266 PEAH230931 PEAJ230649 PEAC230095 PEAE230500 PEAF230300 PEAG230364 PEAH230267 PEAH230932 PEAJ230652 PEAC230096 PEAE230502 PEAF230301 PEAG230365 PEAH230268 PEAH230933 PEAJ230653 PEAC230097 PEAE230503 PEAF230302 PEAG230366 PEAH230269 PEAH230935 PEAJ230654 PEAC230098 PEAE230505 PEAF230305 PEAG230368 PEAH230270 PEAH230935 PEAJ230656 PEAC230099 PEAE230509 PEAF230309 PEAG230370 PEAH230271 PEAH230936 PEAJ230657 PEAC230100 PEAE230512 PEAF230313 PEAG230371 PEAH230273 PEAH230939 PEAJ230658 PEAC230102 PEAE230514 PEAF230315 PEAG230373 PEAH230274 PEAH230940 PEAJ230659 PEAC230103 PEAE230515 PEAF230316 PEAG230374 PEAH230275 PEAH230941 PEAJ230665 PEAC230104 PEAE230517 PEAF230318 PEAG230377 PEAH230276 PEAH230942 PEAJ230666 PEAC230105 PEAE230518 PEAF230319 PEAG230378 PEAH230277 PEAH230943 PEAJ230667 PEAC230106 PEAE230523 PEAF230320 PEAG230379 PEAH230278 PEAH230944 PEAJ230670 PEAC230107 PEAE230524 PEAF230322 PEAG230380 PEAH230279 PEAH230945 PEAJ230675 PEAC230108 PEAE230525 PEAF230323 PEAG230382 PEAH230281 PEAH230946 PEAJ230679 PEAC230109 PEAE230526 PEAF230326 PEAG230385 PEAH230282 PEAH230949 PEAJ230680 PEAC230112 PEAE230528 PEAF230328 PEAG230388 PEAH230285 PEAH230950 PEAJ230682 PEAC230114 PEAE230546 PEAF230336 PEAG230389 PEAH230288 PEAH230956 PEAJ230686 PEAC230115 PEAE230552 PEAF230343 PEAG230391 PEAH230289 PEAH230957 PEAJ230687 PEAC230117 PEAE230556 PEAF230344 PEAG230393 PEAH230290 PEAH230959 PEAJ230690 PEAC230118 PEAE230560 PEAF230346 PEAG230395 PEAH230294 PEAH230960 PEAJ230691 PEAC230119 PEAE230561 PEAF230352 PEAG230397 PEAH230295 PEAH230961 PEAJ230698 PEAC230120 PEAE230562 PEAF230353 PEAG230399 PEAH230297 PEAH230962 PEAJ230699 PEAC230121 PEAE230566 PEAF230356 PEAG230401 PEAH230298 PEAH230963 PEAJ230701 PEAC230122 PEAE230570 PEAF230358 PEAG230403 PEAH230299 PEAH230964 PEAJ230702 PEAC230123 PEAE230572 PEAF230366 PEAG230404 PEAH230300 PEAH230966 PEAJ230703 PEAC230124 PEAE230574 PEAF230371 PEAG230406 PEAH230301 PEAH230967 PEAJ230714 PEAC230125 PEAE230575 PEAF230375 PEAG230407 PEAH230302 PEAH230968 PEAJ230716 PEAC230126 PEAE230576 PEAF230382 PEAG230411 PEAH230303 PEAH230969 PEAJ230717 PEAC230127 PEAE230577 PEAF230385 PEAG230412 PEAH230304 PEAH230970 PEAJ230720 PEAC230128 PEAE230578 PEAF230398 PEAG230413 PEAH230305 PEAH230971 PEAJ230722 PEAC230130 PEAE230579 PEAF230402 PEAG230414 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PEAH230323 PEAH230997 PEAJ230765 PEAC230155 PEAE230617 PEAF230445 PEAG230438 PEAH230325 PEAH230998 PEAJ230766 PEAC230156 PEAE230618 PEAF230446 PEAG230442 PEAH230327 PEAH230999 PEAJ230775 PEAC230158 PEAE230619 PEAF230448 PEAG230444 PEAH230328 PEAH231000 PEAJ230776 PEAC230159 PEAE230625 PEAF230450 PEAG230446 PEAH230330 PEAH231001 PEAJ230778 PEAC230160 PEAE230638 PEAF230452 PEAG230449 PEAH230332 PEAH231002 PEAJ230780 PEAC230161 PEAE230641 PEAF230455 PEAG230451 PEAH230334 PEAH231005 PEAJ230782 PEAC230162 PEAE230644 PEAF230457 PEAG230454 PEAH230336 PEAH231006 PEAJ230784 PEAC230163 PEAE230646 PEAF230458 PEAG230456 PEAH230338 PEAH231007 PEAJ230785 PEAC230164 PEAE230648 PEAF230459 PEAG230459 PEAH230339 PEAH231008 PEAJ230786 PEAC230165 PEAE230650 PEAF230469 PEAG230460 PEAH230340 PEAH231009 PEAJ230787 PEAC230166 PEAE230651 PEAF230470 PEAG230463 PEAH230341 PEAH231011 PEAJ230788 PEAC230167 PEAE230652 PEAF230473 PEAG230464 PEAH230342 PEAH231013 PEAJ230791 PEAC230168 PEAE230655 PEAF230474 PEAG230465 PEAH230343 PEAH231014 PEAJ230793 PEAC230169 PEAE230657 PEAF230477 PEAG230472 PEAH230344 PEAH231016 PEAJ230794 PEAC230170 PEAE230659 PEAF230479 PEAG230473 PEAH230345 PEAH231017 PEAJ230797 PEAC230171 PEAE230661 PEAF230480 PEAG230476 PEAH230346 PEAH231020 PEAJ230801 PEAC230172 PEAE230662 PEAF230483 PEAG230477 PEAH230348 PEAH231025 PEAJ230806 PEAC230173 PEAE230663 PEAF230484 PEAG230478 PEAH230349 PEAH231026 PEAJ230808 PEAC230174 PEAE230664 PEAF230486 PEAG230479 PEAH230350 PEAH231027 PEAJ230811 PEAC230175 PEAE230665 PEAF230490 PEAG230482 PEAH230351 PEAH231028 PEAJ230815 PEAC230176 PEAE230666 PEAF230492 PEAG230483 PEAH230352 PEAH231029 PEAJ230817 PEAC230177 PEAE230669 PEAF230496 PEAG230484 PEAH230353 PEAH231030 PEAJ230819 PEAC230178 PEAE230670 PEAF230499 PEAG230485 PEAH230354 PEAH231031 PEAJ230821 PEAC230179 PEAE230671 PEAF230501 PEAG230486 PEAH230356 PEAH231032 PEAJ230822 PEAC230180 PEAE230672 PEAF230502 PEAG230487 PEAH230357 PEAH231034 PEAJ230824 PEAC230181 PEAE230673 PEAF230504 PEAG230488 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PEAH230396 PEAH231092 PEAJ230904 PEAC230210 PEAE230711 PEAF230615 PEAG230539 PEAH230397 PEAH231094 PEAJ230910 PEAC230211 PEAE230712 PEAF230624 PEAG230541 PEAH230398 PEAH231095 PEAJ230911 PEAC230212 PEAE230715 PEAF230625 PEAG230542 PEAH230399 PEAH231097 PEAJ230916 PEAC230213 PEAE230716 PEAF230627 PEAG230544 PEAH230401 PEAH231098 PEAJ230918 PEAC230214 PEAE230717 PEAF230630 PEAG230545 PEAH230402 PEAH231099 PEAJ230919 PEAC230215 PEAE230720 PEAF230631 PEAG230547 PEAH230404 PEAH231101 PEAJ230926 PEAC230216 PEAE230722 PEAF230633 PEAG230549 PEAH230405 PEAH231102 PEAJ230929 PEAC230217 PEAE230723 PEAF230636 PEAG230551 PEAH230407 PEAH231103 PEAJ230934 PEAC230218 PEAE230724 PEAF230641 PEAG230552 PEAH230408 PEAH231104 PEAJ230935 PEAC230219 PEAE230725 PEAF230644 PEAG230553 PEAH230409 PEAH231106 PEAJ230939 PEAC230220 PEAE230726 PEAF230648 PEAG230555 PEAH230410 PEAH231108 PEAJ230941 PEAC230221 PEAE230727 PEAF230654 PEAG230559 PEAH230411 PEAH231109 PEAJ230942 PEAC230222 PEAE230728 PEAF230666 PEAG230560 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PEAH230489 PEAH231220 PEAJ231054 PEAC230283 PEAE230825 PEAF230806 PEAG230650 PEAH230490 PEAH231221 PEAJ231058 PEAC230287 PEAE230826 PEAF230809 PEAG230651 PEAH230491 PEAH231223 PEAJ231060 PEAC230288 PEAE230828 PEAF230810 PEAG230652 PEAH230492 PEAH231225 PEAJ231061 PEAC230289 PEAE230829 PEAF230812 PEAG230653 PEAH230494 PEAH231226 PEAJ231064 PEAC230290 PEAE230830 PEAF230816 PEAG230654 PEAH230495 PEAH231227 PEAJ231065 PEAC230291 PEAE230831 PEAF230824 PEAG230655 PEAH230497 PEAH231228 PEAJ231068 PEAC230292 PEAE230832 PEAF230827 PEAG230656 PEAH230499 PEAH231229 PEAJ231070 PEAC230293 PEAE230834 PEAF230828 PEAG230658 PEAH230500 PEAH231230 PEAJ231071 PEAC230294 PEAE230835 PEAF230831 PEAG230660 PEAH230501 PEAH231232 PEAJ231072 PEAC230295 PEAE230836 PEAF230834 PEAG230662 PEAH230502 PEAH231233 PEAJ231073 PEAC230296 PEAE230837 PEAF230846 PEAG230663 PEAH230503 PEAH231234 PEAJ231076 PEAC230297 PEAE230838 PEAF230849 PEAG230664 PEAH230504 PEAH231237 PEAJ231078 PEAC230298 PEAE230839 PEAF230862 PEAG230665 PEAH230505 PEAH231238 PEAJ231079 PEAC230299 PEAE230840 PEAF230872 PEAG230668 PEAH230510 PEAH231240 PEAJ231080 PEAC230300 PEAE230841 PEAF230878 PEAG230669 PEAH230511 PEAH231242 PEAJ231084 PEAC230301 PEAE230842 PEAF230884 PEAG230671 PEAH230512 PEAH231243 PEAJ231085 PEAC230302 PEAE230845 PEAF230896 PEAG230672 PEAH230513 PEAH231245 PEAJ231086 PEAC230303 PEAE230848 PEAF230897 PEAG230673 PEAH230514 PEAH231248 PEAJ231087 PEAC230304 PEAE230849 PEAF230909 PEAG230674 PEAH230515 PEAH231251 PEAJ231088 PEAC230305 PEAE230850 PEAF230913 PEAG230675 PEAH230516 PEAH231252 PEAJ231090 PEAC230306 PEAE230851 PEAF230914 PEAG230676 PEAH230520 PEAH231253 PEAJ231093 PEAC230307 PEAE230852 PEAF230920 PEAG230678 PEAH230521 PEAH231254 PEAJ231097 PEAC230308 PEAE230855 PEAF230922 PEAG230680 PEAH230522 PEAH231256 PEAJ231099 PEAC230309 PEAE230856 PEAF230925 PEAG230681 PEAH230523 PEAH231257 PEAJ231100 PEAC230311 PEAE230857 PEAF230931 PEAG230683 PEAH230524 PEAH231258 PEAJ231103 PEAC230312 PEAE230858 PEAF230939 PEAG230685 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• FEI Number: 3002808194
• Recalling Firm/ Manufacturer: Smith & Nephew Medical, Ltd.; 101 Hessle Road; Hull United Kingdom
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
• FDA Determined Cause: Process control
• Action: On 10/02/2024, the firm sent via overnight mail an "Urgent Medical Device Correction Notice" to customers informing them of an issue associated with the RENASYS EDGE batteries if not appropriately maintained and charged, the batteries may become depleted and be unable to recharge. Customers are instructed to: 1. Please inspect your inventory and locate any RENASYS. EDGE devices from the listed product and serial numbers enclosed with this Urgent Medical Device Correction Notice, and quarantine them immediately. a. If you are a sales rep, please work with sales leadership to have device upgraded or returned. b. If you are a distributor/DME, your Care Continuum Director will contact you with next steps once you submit the completed Acknowledgment Form. Note: Based on the regulatory classification and degree of hazard, this field action extends to the retail level. Therefore, it is not required to communicate this notice to the patient at the consumer level. 2. Complete Correction Acknowledgement Form and submit to fieldactions@smith-nephew.com. Firm's contact information: Smith & Nephew, Inc. Global Field Actions 1450 E Brooks Road Memphis, TN 38116 www.smith-nephew.com T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)
• Quantity in Commerce: 1589 units
• Distribution: U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OMP