Medline Industries Recalls Convenience Kits Due to Potential Sterility Assurance Issues
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Medline Industries, LP has voluntarily recalled 551 units of medical convenience kits because calibration issues with sterilization equipment may have compromised 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 "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, MedicalDevices.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While the affected products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the devices.
Which Products Are Affected
The recall involves 551 units distributed nationwide in the United States and worldwide. The affected products include:
ANCILLARY PACK-LF
- Model Number: DYNJ0185290G
- UDI-DI: 10193489378054 (each), 40193489378055 (case)
- Lot Number: 22LBQ336
OPEN HEART ANESTHESIA ICC-A
- Model Number: DYNJ905567A
- UDI-DI: 10193489348927 (each), 40193489348928 (case)
- Lot Numbers: 24BBN429, 23KBI089, 23HBG596, 23FBL644, 23FBG152, 23EBH550, 23CBQ546, 22NBF780, 22LBC300, 22HBP453, 22HBM263, 22HBF686, 22CBY841, 21KBR457, 21KBA253, 21IBH675, 21GBE802, 21EBE777
What You Should Do
Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information regarding returns or credits, contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
Sterility is critical for medical devices used in clinical and surgical environments. A failure to meet the required Sterility Assurance Level could potentially expose patients to pathogens, increasing the risk of infection during medical procedures.
Source
This recall is documented by the FDA under recall number Z-1384-2026.
Original source: FDA Official Notice ↗
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