COPAN FLOQSwabs — Class II medical device recall Z-2440-2021
Terminated recall by Copan Italia, reported 2021-09-15, distributed nationwide. A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at
| Recall number | Z-2440-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Copan Italia, Brescia, N/A, Italy |
| Recall initiated | 2021-07-09 |
| Classified | 2021-09-09 |
| Reported by FDA | 2021-09-15 |
| Terminated | 2024-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 3,029,400 units |
| Reason classes | sterility |
| Lot numbers | 1707256, 1807589, 1808601, 1809095, 1810293, 1810727, 1811060, 1811976, 1812705, 1813221, 1814054, 1814413, 1814717, 1814761, 1814762, 1814763, 1816440, 1816448, 1816451, 1816581, 1816921, 1816964, 1816968, 1817637, 1817638, 1818685, 1818912, 1819144, 1820999, 1821362, 1825274, 2004854, 2008058, 2009380, 2025887, 2027239, 2027871, 2027877, 2027890, 2027915 and 32 more |
| Model numbers | 1127700, 20226, 220250, 220251, 220252, 501CS01, 501CS01.Q20, 501CS01Q100, 502CS01, 503CS01, 503CS01.BD, 503CS01/503CS01.BX, 50U004DS, 50U009DS02, 518CS01, 518CS01.BD, 519C/519C.BX, 519CS01.BD, 525CS01, 528C, 534CS01, 551C, 552C/552C.BX, 553C, 553C.LC and 4 more |
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, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only
Reason for recall
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2440-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.