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Smith & Nephew Medical, Ltd. recall records

3 reported ongoing

3 records in this archive. Latest source date Oct 2, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irri...

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Class IIReported ongoing

Distribution: U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada

Official source
FDA device enforcement

RENASYS 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

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Class IIReported ongoing

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

Official source
FDA device enforcement

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

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Class IIReported ongoing

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

Official source

Reasons in these listed records

  • Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
  • Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

These examples come from this result page and are not a ranking of every recall reason.

Checking Smith & Nephew Medical, Ltd.

Is there a recall on smith & nephew medical, ltd. right now?

This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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