Hull, United Kingdom
Smith & Nephew Medical, Ltd. recalls
2 recalls recorded since 2018, most recently on 2 October 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 October 2024
- Reason
- Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
- Distribution
- U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0516-2025
- 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 exu
Ongoing Class II Medical devices
- Recall started
- 11 March 2024
- Reason
- Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1596-2024, Z-1597-2024
- RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
- RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.