Elevated site urgencyFDA Class II

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

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.

Agency
FDA Device
Recall date
Jun 8, 2026
Status
Ongoing
Company
Medline Industries, LP

1. What product was recalled?

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Quantity: 980 kits

Code or lot text: CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761

LOT
CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
RECALL-NUMBER
Z-2784-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U

Quantity: 980 kits

Code or lot text: DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068

LOT
DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068
RECALL-NUMBER
Z-2781-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

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

Quantity: 980 kits

Code or lot text: DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710

LOT
DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710
RECALL-NUMBER
Z-2779-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

Quantity: 980 kits

Code or lot text: DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601

LOT
DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
RECALL-NUMBER
Z-2787-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105

Quantity: 980 kits

Code or lot text: DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203

LOT
DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203
RECALL-NUMBER
Z-2782-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M

Quantity: 980 kits

Code or lot text: DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622

LOT
DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622
RECALL-NUMBER
Z-2780-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F

Quantity: 980 kits

Code or lot text: DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670

LOT
DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670
RECALL-NUMBER
Z-2785-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J

Quantity: 980 kits

Code or lot text: DYNJ61206J UDI-DI 10198459488597 Lots 25IMF461 25LMG907

LOT
DYNJ61206J UDI-DI 10198459488597 Lots 25IMF461 25LMG907
RECALL-NUMBER
Z-2786-2026

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B

Quantity: 980 kits

Code or lot text: DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889

LOT
DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889
RECALL-NUMBER
Z-2783-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

View source evidence for state distribution
  • California: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
  • Florida: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
  • Maryland: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
  • Pennsylvania: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
  • Texas: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.