Medline Industries, LP recalls Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACKDYNJ0945779UUDI-DI 101953276326564 affected lots25IMC00425JMD94225JMJ44125LMG068
What the firm 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.
DistributionShow detailsHide
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2781-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Karl Storz Endoscopy recalls Flexible Hystero-Fiberscope Kits REF: 11264BBU1
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
- Hysteroscope (And Accessories)
- Packaging change control
Alphatec Spine, Inc. recalls SafeOp Patient Interface
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication betwee…
- Evoked Response Electrical Stimulator
- Software Design Change
Medline Industries, LP recalls Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYN…
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
- Orthopedic Tray
- Process change control
