Medline Convenience Kits Recall 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 is recalling 51,061 units of various convenience kits nationwide 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, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of multiple convenience kits after identifying calibration issues with sterilization and packaging equipment. All products underwent validated cycles, but the issues may affect the sterility assurance level (SAL).
Which Products Are Affected
The recall covers 51,061 units of Medline Convenience Kits distributed nationwide in the United States and worldwide. Affected models include OPEN HEART CDS (CDS840015AQ, CDS840023T), OFF PUMP CABG CDS (CDS840087AI, CDS840087AK, CDS840087AL, CDS840087AM), OPEN HEART (CDS840150S, CDS840150T), and numerous additional models such as CDS840246O, CDS840261AB, CDS840396AA, CDS840428K, CDS840451M, and many others listed under recall number Z-2093-2026. Specific lot numbers and UDI-DI codes are detailed in the FDA enforcement report.
What You Should Do
Healthcare providers and facilities should review inventory for affected lots and follow instructions from Medline Industries, LP regarding returns or further actions.
Why This Matters
Class II recalls address situations where exposure may cause temporary or medically reversible adverse health consequences, highlighting risks to device sterility in surgical kits.
Source
FDA Enforcement Report, recall number Z-2093-2026, initiated January 7, 2026. https://www.fda.gov
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 (1,352 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.