Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE
Summary
The FDA issued a Class II for Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French size by Medline Industries, LP. Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present .
Details
Source
Device Recall
External ID
Z-2783-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
Lot/Code Info: DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889
Quantity Affected: 980 kits
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.
Distribution
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Medline Industries, LP has 511 FDA actions in our database, including 482 recalls and 29 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 511 FDA actions in our database, including 482 recalls and 29 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2783-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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