Reported Dec 21, 2022 · Ongoing
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
- Lot codes and dates
- Lot Numbers
Lot 56185163 exp 2/1/2024Lot 56390466 exp 2/1/2024Lot 56616859 exp 2/1/2024Lot 57390901 exp 1/1/2024Lot 57466813 exp 10/1/2024Lot 57589987 exp 6/1/2024Lot 57674444 exp 6/1/2024
- Lot Numbers
- Amount recalled
- 828 kits
This recall covers 156 products
The agency filed one notice per product. You are reading one of them; the other 155 are below.
143 more are in the archive.
Where it was sold
Why it was recalled
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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