Recall of Medline Breast Pack Kits Due to Regulatory Clearance 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LP is recalling 36 units of Breast Pack kits because the regulatory clearances for certain components have been rescinded.
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, Devices.
What Happened
The recall involves Medline Kits due to the rescinding of 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing.
Which Products Are Affected
The affected product is Medline Kits: BREAST PACK with Model Number DYNJ66777D. The recall includes 36 units, distributed US Nationwide. Specific codes are UDI-DI: 10195327365196 (each), 40195327365197 (case), and Lot Number: 24JBX593. The recall number is Z-1841-2026.
What You Should Do
Consumers should contact the recalling firm, Medline Industries, LP, for instructions, as the initial notification was via letter.
Why This Matters
This voluntary recall affects medical devices distributed nationwide, potentially impacting patient safety due to regulatory issues.
Source
Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1841-2026.
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 (898 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.