Lower riskMedical device recall · FDA · Published September 11, 2023
ROi CPS Burn Pack Recall: Thin Skin Grafts from Affected Blades
ROi CPS recalls Burn Packs with Zimmer Dermatome Blades due to 38 complaints about thin, non-uniform skin grafts. Affected units have specific item numbers and lot dates.
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Take action
Contact the company
📍Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
“ROi CPS Burn Pack Recall: Thin Skin Grafts from Affected Blades.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57337-roi-cps-burn-pack-recall-thin-skin-grafts-from-affected. Based on FDA recall #Z-0070-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2024%22&limit=1).
The FDA announced on September 11, 2023, that ROi CPS LLC voluntarily recalled the GS0008 2Y - Burn Pack - STL due to safety concerns. The medical convenience kit contains Zimmer Dermatome Blades linked to complaints of thin and non-uniform skin grafts.
How to tell if you have it
Brand: ROi CPS
Product: GS0008 2Y - Burn Pack - STL
Item Number: 880082025
UDI/DI: 10194717113805
Lot Number: 97289
Expiration Date: 2025-07-16
Quantity: 103 kits
The hazard
The recalled medical convenience kit contains Zimmer Dermatome Blades that were previously recalled by Zimmer. This action follows 38 complaints received regarding skin grafts being thin and non-uniform when using the affected blades.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since January 3, 2020. Recent brand recalls include a December 26, 2024 Newborn Kit recall for risk of ineffective ventilation and a July 24, 2024 recall of medical kits with Merit syringes. Other recent recalls of similar products include the Kii Low Profile Bladed Dual Pack recall (December 11, 2025), Integra Cytal Burn Matrix 7x10 cm recall (March 19, 2026), and Medline ARTHROSCOPY PACK recall (February 25, 2026).
How to tell if you have this one
Check for item number 880082025, lot number 97289, or expiration date July 16, 2025 on the Burn Pack. The product is sold under the name 'GS0008 2Y - Burn Pack - STL'.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for item number 880082025, lot number 97289, or expiration date July 16, 2025 on the Burn Pack.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “Missouri” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0070-2024 (September 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0070-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.