Class II — Copan Italia
| Recalling firm | COPAN ITALIA Spa |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. |
| Product | COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX,… |
| Quantity | 3,029,400 units |
| Distribution | US nationwide distribution, including Puerto Rico. |
| Initiated | 2021-07-09 |
| Classified | 2021-09-09 |
| Terminated | 2024-01-25 |
| Recall number | Z-2440-2021 |
| 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 — Copan Italia (Z-2440-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88437/
Alerts for COPAN ITALIA Spa
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.