CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Renasys Edge Canister With Solidifier- Indicated recalled
Smith & Nephew Medical is recalling Renasys Edge Canister With Solidifier- Indicated for patients who would benefit from a, distributed nationwide in the US. The recall was initiated on 11 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1596-2024
- FDA event ID
- 94248
- Recalling firm
- Smith & Nephew Medical, Hull
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2024
- FDA classified
- 18 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2024 | Recall initiated by company | |
| 18 Apr 2024 | Classified by FDA | +38 days |
| 24 Apr 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Questions about this recall
Is Renasys Edge Canister With Solidifier- Indicated for patients who would benefit from a recalled?
Yes. Smith & Nephew Medical recalled Renasys Edge Canister With Solidifier- Indicated for patients who would benefit from a on 11 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1596-2024.
Why was it recalled?
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Which lots are affected?
GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Smith & Nephew Medical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Renasys Edge The Renasys¿ Edge pump is indicated recalled | Smith & Nephew Medical | Device Malfunction | 13 states |
| Device | CLASS II | Renasys Edge Canister With Solidifier- Indicated recalled | Smith & Nephew Medical | Particulate Matter | Nationwide |
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