Medline Industries Recalls Chest/Breast Convenience Kits Due to Sterility Concerns
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 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 recall 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 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, MedicalDevices.
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.
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 (1,717 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.