Medline Urology Robotic Procedure Pack Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries is recalling 980 urology procedure kits containing Bard Silastic Foley Catheters due to potential harmful raw material on the catheter surface.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP initiated a voluntary recall of convenience kits containing Bard Silastic Foley Catheters after the catheters were recalled by their manufacturer due to an increased amount of raw material on the surface. The issue may result in staining on the catheter surface, and the raw material present in increased amounts may be harmful.
Which Products Are Affected
The recall affects Medline UROLOGY ROBOTIC PROCEDURE PACK (DYNJ0945779U) containing Bard Silastic Foley Catheters in French sizes 16, 18, and 20 with 5cc balloons. A total of 980 kits are affected. Affected lots are 25IMC004, 25JMD942, 25JMJ441, and 25LMG068 (UDI-DI 10195327632656). Distribution was limited to the states of CA, FL, MD, PA, and TX.
What You Should Do
Consumers should stop using the affected kits and contact Medline Industries, LP for return or refund instructions. The recall number is Z-2781-2026.
Why This Matters
The recalled kits contain catheters that may expose users to potentially harmful raw material on the device surface.
Source
FDA Recall Z-2781-2026 - Medline Industries, LP, Northfield, IL
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,164 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.