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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 980
Distribution
Part of a larger recall action
This product is one of 9 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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