SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1 — Class II medical device recall Z-2042-2020
Terminated recall by Medline Industries Inc, reported 2020-05-27, distributed nationwide. Loose silicone particulate was found to be present on the shaft of the silicone catheters.
| Recall number | Z-2042-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2020-05-18 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2023-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 330 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 40884389034416 |
| Lot numbers | 287181201 |
| Model numbers | DYND11552 |
Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
Reason for recall
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
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-2042-2020. 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.