RENASYS EDGE recallZ-1597-2024 · Smith & Nephew Medical, Ltd. · initiated Mar 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Medical, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] if you have any questions. If you have any questions or concerns regarding this recall please contact [email protected].
Recall details
- Recall number
- Z-1597-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 11, 2024
- Posted by the FDA
- Apr 18, 2024
- Recalling firm
- Smith & Nephew Medical, Ltd.
- Quantity
- 675 units
- Product code
- OMP
- FDA submissions
- K223041
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Product description
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
Code information (models, lots, serial numbers)
GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RENASYS EDGE 66803140Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K223041 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RENASYS EDGE 66803126Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump1 recall28 reports
- RENASYS EDGE 66803139Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94248).
- Z-1596-2024 · Open, ClassifiedRENASYS 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
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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