Medline Industries Recall of Medical Device Kits
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Medline Industries, LP is recalling over 160,883 units of various medical device kits due to rescinded regulatory clearances for certain components.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, cpsc, Devices.
Medline Industries Medical Device Kits Recall
What Happened
Medline Industries, LP is voluntarily recalling the affected medical device kits because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Which Products Are Affected
The recall involves multiple models of medical device kits, including but not limited to: CATH LAB CDS (Model: CDS840228F), IR PACK (Model: DYNDH2104), and CARDIAC CATH PACK-LF (Model: DYNJT2164M), among others listed in the recall notice. A total of 160,883 units are affected, distributed nationwide in the United States. Specific lots include various numbers such as 25ALA420 for CDS840228F and 25DBR609 for DYNDH2104. Model numbers and UDIs are provided in the source data, with the official recall number Z-1835-2026.
What You Should Do
Consumers should contact Medline Industries, LP for instructions on returning the affected products. The initial firm notification was made via letter, and further details can be obtained from the recalling firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall highlights potential regulatory compliance issues in medical devices, which could affect patient safety and require healthcare providers to verify product approvals to ensure proper use.
Source
Attribution: FDA Recall Notice Z-1835-2026. For more information, visit the FDA website at https://www.fda.gov.
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 (1,468 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.