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.
Reported: December 4, 2024 Initiated: October 2, 2024 #Z-0516-2025
Product Description
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.
Reason for Recall
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Details
- Recalling Firm
- Smith & Nephew Medical, Ltd.
- Units Affected
- 1589 units
- Distribution
- U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
- Location
- Hull
Frequently Asked Questions
What product was 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.. Recalled by Smith & Nephew Medical, Ltd.. Units affected: 1589 units.
Why was this product recalled? ▼
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0516-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11