RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT),…
Medical device recall Z-0516-2025. Published in FDA’s Enforcement Report on Dec 4, 2024.
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 4, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 13 states named in where it went
- 1589 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 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?
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1589 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 35,183 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.
U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
The states and territories these words name
13 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Florida
- Hawaii
- Indiana
- Kentucky
- Nebraska
- New York
- Pennsylvania
- South Carolina
- Tennessee
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Oct 2, 2024.
- FDA classified it on Nov 22, 2024.
- FDA’s Enforcement Report published it on Dec 4, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew Medical, Ltd., of Hull, United Kingdom.
- 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 35,183 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.