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ACE+

STERILMED, INC. · Model HAR23R · UDI-DI 10888551045100

NUJ Prescription
1
510(k) clearances
827
Adverse events (2 deaths)
20
Recalls
22
Facilities

Description

Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 23cm

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.