Smith & Nephew Medical, Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1597-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 11, 2024

Date Posted: April 24, 2024

Recall Number: Z-1597-2024

Event ID: 94248

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

Status: Ongoing

Product Quantity: 675 units

Code Information:

GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Chile.

Voluntary or Mandated:

Voluntary: Firm initiated