CelluTome Epidermal Harvesting System Harvester — Class II medical device recall Z-0933-2015
Terminated recall by KCI USA, INC., reported 2015-01-14, distributed nationwide. KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTo
| Recall number | Z-0933-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, INC., San Antonio, TX, United States |
| Recall initiated | 2014-11-19 |
| Classified | 2015-01-07 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, DE, ES, FR, GB, IE, IT, NL, SE, TR, ZA |
| Lot numbers | 2498886, 2510874, 2537872, 2537879, 2545871, 2556866, 3249660000, 3249840000, 3249980000, 3249990000, 3250010000, 3250050000, CT-H50 |
| Model numbers | CT-H25, CT-H50 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0933-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.