Data Foundry

Medical device recalls 2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters — Class II medical device recall Z-2779-2026

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 numberZ-2779-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-06-08
Classified2026-07-23
Reported by FDA2026-07-29
DistributedNationwide (US)
Quantity980 kits
UPC / GTIN / UDI-DI10198459644764
Lot numbers26ABL226, 26BBD710

Product

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I

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-2779-2026. 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.