Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 14, 2015
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.
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 d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Kci USA, INC. recalled CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured … - a moderate-severity action.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured … was recalled by Kci USA, INC. in January 14, 2015. Reason: KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluT…. Check the official notice for the remedy. Verify recall #Z-0933-2015 with the FDA Devices before acting.
The recall
Kci USA, INC. issued this moderate-severity FDA Devices recall-KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluT….
- Moderate
- severity level
- Class II
- classification
- January 14, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0933-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0933-2015) was formally reported on January 14, 2015, with the manufacturer initiating the action on November 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Kci USA, INC. is listed as the recalling firm, operating out of San Antonio, TX. Federal records list the affected scope as 1,139/5 Packs.
The documented reason for this recall is: 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 pro… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,139/5 Packs
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0933-2015 |
| Date reported | January 14, 2015 |
| Date initiated | November 19, 2014 |
| Recalling firm | Kci USA, INC. |
| Firm location | San Antonio, TX |
| Affected scope | 1,139/5 Packs |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0933-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Kci USA, INC.. Units affected: 1,139/5 Packs.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0933-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0933-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 14, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.