FDA Recall of Medline PICC TRAY Devices
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a voluntary recall of 20 units of Medline PICC TRAY due to rescinded regulatory clearances for certain components.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 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 the PICC TRAY because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. This is a Class II recall initiated voluntarily by the firm.
Which Products Are Affected
The affected product is Medline Kits: PICC TRAY, Model Number: DYNJ41648A. The recall involves 20 units with the following details: UDI-DI 10198459062834 (each) and 40198459062835 (case), Lot Numbers: 25CLA242 and 24LLA758. Distribution was US Nationwide, with no specific date ranges provided.
What You Should Do
Consumers should contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, as the initial notification was made via letter. Follow any instructions from the firm for returns or refunds related to Recall Number Z-1837-2026.
Why This Matters
This recall highlights potential regulatory issues with medical devices that could affect patient safety, emphasizing the importance of compliance in the medical industry. It impacts a small number of units distributed nationwide in the United States.
Source
Attribution: FDA Recall Number Z-1837-2026, Event ID 98599. For more information, visit the FDA website.
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 (1,264 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.