Medline Industries Recalls Medical Devices Over 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Medline Industries, LP is recalling 513 units of specific medical kits due to rescinded regulatory clearances for certain components.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 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, medical-devices.
What Happened
Medline Industries, LP is recalling certain medical kits because the 510(k) regulatory clearances for components such as Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which Products Are Affected
The affected products include:
- ENT PACK, Model Number: DYNJ59030B, with UDI-DI: 10198459176920 (each), 40198459176921 (case), and Lot Number: 24KBL574.
- ENT, Model Number: DYNJ908586C, with UDI-DI: 10198459058677 (each), 40198459058678 (case), and Lot Numbers: 24IBJ666, 24JBM014, 24KBE220, 24LBJ174, 25ABW145, 25CBK525, 25EBA897, 25GBK561.
- LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C, with UDI-DI: 10195327054519 (each), 40195327054510 (case), and Lot Number: 25FBA927. A total of 513 units are affected, distributed nationwide in the United States. The recall number is Z-1839-2026.
What You Should Do
Consumers should stop using the affected products immediately and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for instructions on returns and refunds, as the recall was initiated via letter.
Why This Matters
This recall involves medical devices that may pose risks due to rescinded regulatory clearances, potentially affecting patient safety in the United States.
Source
Information from the FDA recall notice, recall number Z-1839-2026.
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 (1,355 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.