Medline Convenience Kits Recall Issued
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Medline Industries, LP is recalling 826 units of lithotomy packs and lap basins due to potential sterility assurance issues from equipment calibration problems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 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, medical-devices.
What Happened
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Which Products Are Affected
The recall covers 826 units of Medline Convenience Kits distributed nationwide in the United States and worldwide. Affected products include:
- LITHOTOMY PACK, Model Number: DYNJ83185 (multiple lots including 22LDA486, 23CDA474, 23CDB552, 23FDC392)
- LITHOTOMY PACK, Model Number: DYNJ83185A (multiple lots including 23HDB637, 24CDA984, 24CDB327, 24CDB829, 24DDB769, 24EDB468, 24FDB302, 24GDB922, 24IDB525, 24KDB955)
- LAP BASIN, Model Number: DYNJVB91109D (lot 25LLA489)
UDI-DI codes and additional lot details are provided in the recall notice. The recall number is Z-2100-2026. Classification is Class II.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the recalled products.
Why This Matters
The calibration issues have the potential to impact the sterility assurance level of the affected devices.
Source
FDA recall Z-2100-2026, Medline Industries, LP, Northfield, IL.
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 (1,323 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.