FDA Medical Device Recalls (openFDA)
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 number
- Z-1597-2024
- Recalling firm
- Smith & Nephew Medical, Ltd.
- 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
- Status
- Open, Classified
- Initiated
- 2024-03-11
- Posted
- 2024-04-18
- Terminated
- not on file
- Reason
- Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Lot, serial or model codes
- GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
- 510(k) numbers
- ["K223041"]
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 3002808194
- Firm city
- Hull
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28