ECOLAB MICROTEK Rolled Probe Cover — Class III medical device recall Z-2332-2018
Terminated recall by ECOLAB INC, reported 2018-07-11, distributed in CA, IL, LA, SC, TX, WI. The incorrect IFU was shipped with the product.
| Recall number | Z-2332-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ECOLAB INC, Saint Paul, MN, United States |
| Recall initiated | 2017-11-22 |
| Classified | 2018-06-29 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-07-22 |
| Distributed | CA, IL, LA, SC, TX, WI |
| Quantity | 65 cases |
| Lot numbers | D151871, D151961, D161861, D162001, D162911 |
| Model numbers | PC0905 |
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).
Reason for recall
The incorrect IFU was shipped with the product.
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-2332-2018. 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.