Recall of Medline Breast Pack Kits Due to Regulatory Clearance Issues

Source: FDA · United States

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LP is recalling 36 units of Breast Pack kits because the regulatory clearances for certain components have been rescinded.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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 36 units of Breast Pack kits because the regulatory clearances for certain components have been rescinded.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.