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Medline Convenience Kits with Bard Silastic Foley Catheters
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MEDICAL DEVICE RECALLMODERATE

Medline Convenience Kits with Bard Silastic Foley Catheters

Medline recalls convenience kits with Bard Silastic Foley Catheters (sizes 16, 18, 20) due to surface raw material risk.

What to do

Stop using the affected kits and contact Medline Industries, LP for instructions on returning the product and obtaining a replacement or refund.

Recalled
Listed
Updated
Recall No.
Z-2784-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
99301
Status
ONGOING

Recall at a glance

Quantity recalled
980 kits

Why it was recalled

Medline is recalling convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons. The catheters were recalled by the manufacturer due to increased raw material on the catheter surface, which may cause staining and could be harmful.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

ProductLot codeRecall #UDI-DI
ROBOTIC CDS980523M25KBJ177, 25LBO527, 26ABT761Z-2784-202610195327508913
UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U25IMC004, 25JMD942, 25JMJ441, 25LMG068Z-2781-202610195327632656
KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I26ABL226, 26BBD710Z-2779-202610198459644764
KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G25GBG086, 25JBF391, 25KBA114, 25KBN017, 25LBQ601Z-2787-202610198459156991
NON MB DAVINCI LITHOTOMY SM PK DYNJT610525JBM474, 25LBS203Z-2782-202610198459539381
DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M25HMF458, 25LME235, DYNJ68477M, 26CMK219, 26EMG622Z-2780-202610198459487866, 10198459678738
PROSTATE ROBOTIC DYNJ901822B25KBA955, 26CBL889Z-2783-202610195327319182
SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J25IMF461, 25LMG907Z-2786-202610198459488597
RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F25GLA905, 25HLA240, 25HLA894, 25JLA091, 25KLA775, 25LLA985, 26ALA670Z-2785-202610198459315572

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification