Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0507-2025 — V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

U.S. FDA — Device Enforcement · United States · 2024-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0507-2025
Date of alert: 2024-11-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: KCI USA, INC.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00849554000636

Reported risk: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0507-2025 — V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

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