Recall of Medline DYNJ44813D 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Medline Industries, LP is voluntarily recalling 1720 units of their LABOR PACK-22025208-LF kits due to rescinded 510(k) regulatory clearances for certain components.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.
Recall of Medline DYNJ44813D Kits
What Happened
The recall is due to the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing being rescinded.
Which Products Are Affected
The affected product is Medline Kits: LABOR PACK-22025208-LF, Model Number: DYNJ44813D. A total of 1720 units are involved, with specific lot numbers including 21CBJ477, 21GBE184, 21GBJ527, 21HBL388, 21IBT013, 21LBS718, 22BBD935, 22CBA262, 22FBM910, 22LBQ838, 23FBS838, 23IBD099, 23KBA057, 24ABJ743, 24EBG776, 24FBC225, 24IBW215, 24LBU055, 22HBG782, and 25DBP554. UDI-DI codes are 10193489467642 for each unit and 40193489467643 for cases. The products were distributed nationwide in the United States.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for instructions on returns or refunds related to this recall.
Why This Matters
This recall addresses potential regulatory non-compliance in medical devices, which could impact product safety and user health, emphasizing the importance of adhering to FDA standards.
Source
FDA Recall Number: Z-1845-2026
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 (1,238 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.