Regard™ GS00082YRecalls & reported problems
Roi Cps, LLC · BURN · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Sep 11, 2023Class IIOpen, Classified
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.
Z-0070-2024 · Root cause: Other · Recall details · FDA record ↗
Other Burn Kit Without Drug devices
- Medline Industries, Inc. DYNJT3437Medline Industries, Inc. · Burn kit without drug2 recalls1 report
- Medline Industries, Inc. DYNJ42829BMedline Industries, Inc. · Burn kit without drug2 recalls0 reports
- Medline Industries, Inc. DYNJ15668RMedline Industries, Inc. · Burn kit without drug2 recalls0 reports
- Medline Industries, Inc. DYNJ63331DMedline Industries, Inc. · Burn kit without drug1 recall0 reports
- Medline Industries, Inc. DYNJ901793LMedline Industries, Inc. · Burn kit without drug1 recall0 reports
- Medline Industries, Inc. CDS983465MMedline Industries, Inc. · Burn kit without drug1 recall0 reports
- Medline Industries, Inc. DYNJ0781678SMedline Industries, Inc. · Burn kit without drug1 recall0 reports
- Medline Industries, Inc. DYNJ82534Medline Industries, Inc. · Burn kit without drug1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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