FDAFDA recall Z-2785-2026 · Jul 29, 2026
Medline Industries, LP: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall
Recall found
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670
- Quantity
- 980 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-08
Source: openFDA enforcement record Z-2785-2026 · search recall number Z-2785-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.