Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters — Class II medical device recall Z-2780-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-29, distributed nationwide. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to i
| Recall number | Z-2780-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 980 kits |
| UPC / GTIN / UDI-DI | 10198459487866, 10198459678738 |
| Lot numbers | 25HMF458, 25LME235, 26CMK219, 26EMG622, DYNJ68477M |
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
Reason for recall
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
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-2780-2026. 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.