Medline DAVINCI PROSTATE PACK Kits 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 convenience kits containing Bard Silastic Foley Catheters due to potential harmful raw material on catheter surfaces.
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 catheter surface. This issue may result in staining and potential harm from the raw material.
Which Products Are Affected
The recall affects Medline convenience kits: DAVINCI PROSTATE PACK (DYNJ68477L and DYNJ68477M) containing Bard Silastic Foley Catheters in French sizes 16, 18, 20 with 5cc balloons. Affected lots are 25HMF458, 25LME235 for DYNJ68477L (UDI-DI 10198459487866) and 26CMK219, 26EMG622 for DYNJ68477M (UDI-DI 10198459678738). A total of 980 kits were distributed nationwide in the United States, specifically in CA, FL, MD, PA, and TX. The FDA recall number is Z-2780-2026, classified as Class II.
What You Should Do
Consumers in possession of the affected kits should refer to the recall notice for further guidance on handling the products.
Why This Matters
The recall addresses a potential risk of harm from raw material on urinary catheter surfaces in affected kits distributed across multiple states.
Source
FDA recall Z-2780-2026 (ongoing Class II device recall by Medline Industries, LP)
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 (1,263 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.