FDA recall, , Moderate risk
Medline Convenience Kits Containing Bard Silastic Foley Catheters
Medline convenience kits contain Bard Silastic Foley Catheters with increased raw material on the surface, which may be harmful.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP of Northfield, Illinois, recalled Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons, because the catheters were recalled by the manufacturer due to an increased amount of raw material present on the surface of the catheter, which may be harmful and may result in staining on the catheter surface.
The recall began on June 8, 2026, and was added to the FDA's Enforcement Report on July 23, 2026. The kits were distributed in California, Florida, Maryland, Pennsylvania, and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
9 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Robotic CDS980523M
- UDI-DI
- 10195327508913
- Lot code
- 25KBJ177
- 25LBO527
- 26ABT761
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Urology Robotic Procedure Pack DYNJ0945779U
- UDI-DI
- 10195327632656
- Lot code
- 25IMC004
- 25JMD942
- 25JMJ441
- 25LMG068
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Kit Robotics Urology Prostate DYKMBNDL116I
- UDI-DI
- 10198459644764
- Lot code
- 26ABL226
- 26BBD710
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Kit Robotics Urology Prostate DYKMBNDL116G
- UDI-DI
- 10198459156991
- Lot code
- 25GBG086
- 25JBF391
- 25KBA114
- 25KBN017
- 25LBQ601
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB Davinci Lithotomy SM PK DYNJT6105
- UDI-DI
- 10198459539381
- Lot code
- 25JBM474
- 25LBS203
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Davinci Prostate Pack DYNJ68477L DYNJ68477M
- UDI-DI
- 10198459487866
- 10198459678738
- Lot code
- 25HMF458
- 25LME235
- DYNJ68477M
- 26CMK219
- 26EMG622
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. Prostate Robotic DYNJ901822B
- UDI-DI
- 10195327319182
- Lot code
- 25KBA955
- 26CBL889
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-Laparoscopic Prostate PAC DYNJ61206J
- UDI-DI
- 10198459488597
- Lot code
- 25IMF461
- 25LMG907
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-Davinci Prostate Accessory DYNJ63392F
- UDI-DI
- 10198459315572
- Lot code
- 25GLA905
- 25HLA240
- 25HLA894
- 25JLA091
- 25KLA775
- 25LLA985
- 26ALA670
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida, Maryland. Pennsylvania, and Texas.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99301
- Recall numbers
- Z-2779-2026 to Z-2787-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
