Reported Dec 4, 2024 · Ongoing

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may…

Smith & Nephew Medical, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew Medical, Ltd. · 101 Hessle Road · Hull · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • Model Numbers
    • 66803126
    • 66803126LRC
  • UDI-DI codes05000223498634
  • Serial Numbers

    2,956 of 2,956 codes

    • 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
    PE
Amount recalled
1589 units

Where it was sold

Why it was recalled

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.