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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Smith & Nephew Medical, Ltd.: RENASYS EDGE Canisters Recalled for Pump Damage from Black Particles

Agency Publication Date: April 18, 2024
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Summary

Smith & Nephew Medical, Ltd. has recalled approximately 7,570 RENASYS EDGE canisters (300ml and 800ml sizes) used for Negative Pressure Wound Therapy (NPWT). These devices are being recalled because black particles from the canister's carbon filter can break loose and enter the suction pump, potentially damaging the motor and causing the system to fail during treatment. If you are using one of these affected canisters, contact your healthcare provider or the manufacturer for further instructions regarding a potential replacement or refund.

Risk

The black particulate matter can cause internal damage or mechanical failure of the suction pump, which may lead to an interruption in wound healing therapy or necessitate more frequent device replacements.

What You Should Do

  1. Check your RENASYS EDGE canister to see if it matches the affected product numbers: 66803139 (300ml) or 66803140 (800ml).
  2. Verify the lot numbers on your product packaging. Affected 300ml canisters include lot numbers 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, or 1016044. Affected 800ml canisters include lot numbers 1016051 or 1017549.
  3. Check the GTIN (Global Trade Item Number) on the label: (01)05000223501044 for the 300ml version or (01)05000223501082 for the 800ml version.
  4. If you identify an affected canister, contact your healthcare provider or Smith & Nephew Medical, Ltd. to discuss next steps and ensure your wound therapy continues safely.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit the FDA website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: RENASYS EDGE 300ML CANISTER WITH Solidifier
Model / REF:
66803139
Lot Numbers:
1016448
1016478
1016537
1016773
1017147
1017417
1017418
1017912
1016044
Product: RENASYS EDGE 800ML CANISTER WITH Solidifier
Model / REF:
66803140
Lot Numbers:
1016051
1017549

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94248
Status: Active
Manufacturer: Smith & Nephew Medical, Ltd.
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United Kingdom
Units Affected: 2 products (6895 units; 675 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.