Medline Urology Robotic Procedure Packs Recalled Due to Catheter Surface Contamination
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with a high-risk hazard (potential harm from raw material) where injury has not yet been reported, and the FDA has classified it as Class II.
Plain-English summary
Medline Industries, LP is recalling Medline convenience kits that contain Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons. The affected kits are part of the UROLOGY ROBOTIC PROCEDURE PACK (DYNJ0945779U).
The manufacturer initiated this recall because an increased amount of raw material was found on the surface of the catheters. This issue may cause the catheters to exhibit staining on the surface, and the excess raw material may be harmful to users.
This recall affects 980 kits distributed nationwide in California, Florida, Maryland, Pennsylvania, and Texas. Affected lots include 25IMC004, 25JMD942, 25JMJ441, and 25LMG068.
The recalled product
- Product
- Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
- Manufacturer
- Medline Industries, LP
- Hazard
- contamination
- material-residue
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- SevereMEDLINE Medical Procedure Kits Containing Bupivacaine Recalled Due to Drug Ineffectiveness
FDA (Devices) · 2026-07-29
- HighFARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
FDA (Devices) · 2026-07-29
- HighBoston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility
FDA (Devices) · 2026-07-29
- HighPenumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk
FDA (Devices) · 2026-07-29