Medline Industries Recalls Convenience Kits Over Potential Sterility Assurance Issues
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Medline Industries, LP has issued a voluntary recall for 32 units of 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 Worldwide. 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, medical-device.
What Happened
Medline Industries, LP has initiated a voluntary Class II recall of specific convenience kits after identifying calibration issues with equipment used for sterilization and packaging. While the products were processed through 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 32 units of the following medical device:
- Product Name: Medline Convenience Kits: WMC I D PACK-LF
- Model Number: DYNJ50806L
- Lot Number: 23FBK937
- UDI-DI: 10195327344672 (each), 40195327344673 (case)
- Recall Number: Z-1403-2026
The affected products were distributed worldwide, including nationwide across the United States.
What You Should Do
Consumers and healthcare providers should immediately inspect their inventory for the affected lot number (23FBK937). Medline Industries notified customers of the issue via a formal letter initiated on January 7, 2026. If you are in possession of the recalled kits, follow the instructions provided in the firm's notification regarding the return or quarantine of the product. For further inquiries, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.
Why This Matters
Compromised sterility in medical kits poses a risk of infection or other adverse health complications for patients. This recall ensures that potentially non-sterile equipment is removed from clinical use to maintain patient safety.
Source
Recall information provided by the FDA.
Original source: FDA Official Notice ↗
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