Z-1597-2024Class II

RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump...

Name: Z-1597-2024 RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump...
Creator: Smith & Nephew Medical, Ltd.
Published: 2024-03-11
License: https://open.fda.gov/license/

Smith & Nephew Medical Ltd / initiated 2024-03-11 / Open, Classified

FDA source

Smith & Nephew Medical, Ltd. began a recall of RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product... on 2024-03-11. FDA classified it as Class II and gives the reason as "Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1597-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-11
Posted: 2024-04-18
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
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: 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: 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 [email protected] if you have any questions. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 675 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Product codes and lots: GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1597-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1596-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-18
Z-1597-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-18

Product code OMP

K223041Class IIRenasys Edge (66803126)Smith & Nephew Medical Limited / cleared 2022-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)