Class III — ECOLAB INC
| Recalling firm | Ecolab Inc |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The incorrect IFU was shipped with the product. |
| Product | ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe). |
| Quantity | 65 cases |
| Distribution | US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution. |
| Initiated | 2017-11-22 |
| Classified | 2018-06-29 |
| Terminated | 2020-07-22 |
| Recall number | Z-2332-2018 |
| 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 III recall — ECOLAB INC (Z-2332-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80160/
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