Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Recalled by KCI USA, INC. Due to KCI has received reports that, in a small...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact KCI USA, INC. directly.
Affected Products
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
Quantity: 1,139/5 Packs
Why Was This Recalled?
KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About KCI USA, INC.
KCI USA, INC. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report