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Smith and Nephew

Provision · Model AC4040-01 · UDI-DI 00810041638540

NUJ Prescription
10
510(k) clearances
772
Adverse events (2 deaths)
20
Recalls
23
Facilities

Recalls

DateFirmReason
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge
2025-10-01Medline Industries, LPMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodge

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.