Class II — Dukal Corp.
| Recalling firm | DUKAL LLC |
|---|---|
| Registered facility | DUKAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Intact carton revealed presence of shredded burn sheets |
| Product | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection. |
| Quantity | 12095 cases/12 Packs per case/1 sheet |
| Distribution | Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada |
| Initiated | 2017-06-01 |
| Classified | 2017-12-12 |
| Terminated | 2018-07-19 |
| Recall number | Z-0233-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dukal Corp. (Z-0233-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77673/
Alerts for DUKAL LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.