Medline convenience kits containing Bard Silastic Foley… recallZ-2787-2026 · Medline Industries, LP · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On June 8, 2026, the firm began notifying customers through First-Class Mail and email. Customers were instructed to over-label affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Recall details
- Recall number
- Z-2787-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 23, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 980 kits
- Product code
- OKV
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Product description
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Code information (models, lots, serial numbers)
DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYKMBNDL116GMedline Industries, Inc. · Obstetrical kit4 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99301).
- Z-2781-2026 · Open, ClassifiedMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
- Z-2783-2026 · Open, ClassifiedMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
- Z-2784-2026 · Open, ClassifiedMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
- Z-2785-2026 · Open, ClassifiedMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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