Smith & Nephew Medical, Ltd. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Smith & Nephew Medical, Ltd.
Lot Codes / Batch Numbers
GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Products Sold
GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Smith & Nephew Medical, Ltd. is recalling RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction due to Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Recommended Action
Per FDA guidance
Smith & Nephew Medical Ltd. issued Urgent Medical Device Recall Notice R-2024-02 on March 11, 2024 via overnight mail. Letter states reason for recall, health risk and action to take: 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. If your customer contacts you regarding a pump failure: 1. Contact S+N Clinical Hotline (800-876-1261) with any questions. 2. Please ensure you provide a replacement as soon as possible. Replacement Stock. Smith+Nephew is supplying replacement stock quantities in parallel with this notice. Please contact AWM.returns.cr@smith-nephew.com if you have any questions. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026