Medline Industries Recalls Medical Devices Due to Regulatory Issues
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Medline Industries, LP is recalling 58,836 units of certain medical kits because their regulatory clearances were rescinded, affecting nationwide distribution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 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 is recalling certain medical devices because the 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which Products Are Affected
The affected products are: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A. A total of 58,836 units are involved, distributed nationwide in the United States. Specific lot numbers include: for DYNJSYR10CWRB, lots such as 22IBH073, 22IBH620, 22KBU236, and others up to 25CBN329; for VASCSLPOFF1, lots 24KBI875 and 23KBD992; for VASC1018A, lots 25BBG137, 25BBI161, and 25ABG686. UDI-DIs include 10889942540570 for DYNJSYR10CWRB, 10889942405527 for VASCSLPOFF1, and 10889942337033 for VASC1018A.
What You Should Do
Consumers who have these products should contact Medline Industries, LP for instructions, as the recall was initiated via letter.
Why This Matters
This recall involves over 58,000 units of medical devices used in procedures, potentially affecting patient safety due to regulatory issues.
Source
FDA recall notice Z-1833-2026, attributed to the U.S. Food and Drug Administration (FDA).
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 (1,259 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.