Medline Industries Recalls Chest/Breast Convenience Kits Due to Sterility Concerns

FDA Recalls high FDA · · United States

Medline Industries, LP has issued a voluntary recall for 150 units of Chest/Breast convenience kits due to equipment calibration issues that may compromise product sterility.

What this fda recalls alert tells you, and what most readers miss

This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" 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 an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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.

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What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits used for chest and breast procedures. The company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization and packaging cycles, the identified calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the recalled products.

Which Products Are Affected

The recall affects 150 units of the following product:

  • Product Name: Medline Convenience Kits: CHEST/BREAST-LF
  • Model Number: DYNJ83950
  • Recall Number: Z-1412-2026
  • Affected Lot Numbers: 24DBT832, 24CBH626, 23LBR075, 23FBF248, and 23CBG610
  • UDI-DI: 10195327318925 (each), 40195327318926 (case)

These products were distributed nationwide across the United States and worldwide.

What You Should Do

Medline notified affected customers via letter starting in January 2026. Healthcare providers and facilities should immediately check their inventory for the affected lot numbers listed above. Any matching products should be sequestered and handled according to the instructions provided in the firm's notification letter. For further information or questions regarding the return process, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

Sterility is critical for medical devices used in surgical procedures. A failure to meet the required Sterility Assurance Level (SAL) could increase the risk of infection for patients undergoing chest or breast procedures.

Source

Information provided by the FDA under Recall Event ID 98329.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
Medline Industries, LP has issued a voluntary recall for 150 units of Chest/Breast convenience kits due to equipment calibration issues that may compromise product sterility.
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 "high" severity. Take precautions and monitor for updates.
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 alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.