Medline C-Section Kits Recall Due to Sterility Issues
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Medline Industries, LP is recalling 12,529 units of various C-section convenience kits nationwide due to potential impacts on sterility assurance from equipment calibration issues.
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, MedicalDevices.
What Happened
Medline Industries, LP initiated a voluntary recall of multiple C-section convenience kits after identifying calibration issues with sterilization and packaging equipment. Although products underwent validated cycles, the issues may affect the sterility assurance level (SAL).
Which Products Are Affected
The recall covers 55 models of Medline Convenience Kits including C-SECTION PACK, C-SECTION CDS, C-SECTION TRAY, C-SECTION PACK-LF, and similar variants with model numbers such as CDS820080N, CDS983523G, CDSCCR611O, CDSCCR611P, DYNJ0101616I, DYNJ15494G, DYNJ19529O through DYNJ19529S, DYNJ21550Q, DYNJ23544F, DYNJ32632F, DYNJ35100I, DYNJ35902F, DYNJ38801F, DYNJ40129C, DYNJ41444F, DYNJ49224I, DYNJ49771A, DYNJ49771B, DYNJ52387I, DYNJ53528B, DYNJ55367A, DYNJ56523C, DYNJ59387L through DYNJ59387P, DYNJ62707B, DYNJ64549B, DYNJ67347A, DYNJ69778A, DYNJ900602I, DYNJ900602K, DYNJ902134C, DYNJ902182J, DYNJ902938J, DYNJ904329D, DYNJ904453C, DYNJ904697F, DYNJ906255B, DYNJ906966G, DYNJ907999A, DYNJ908350C, DYNJ909058, DYNJ909475A, DYNJ909507, DYNJ910199, DYNJ910199A, DYNJT3407, OBP211C, and PHS583549002B. Affected lots are specified by UDI-DI and lot numbers in FDA records. A total of 12,529 units distributed nationwide in the United States and worldwide are affected. This is FDA Class II recall Z-2110-2026.
What You Should Do
Consumers and facilities should immediately check inventory for the listed products and lots. Stop using affected items and contact Medline Industries, LP for return or disposition instructions.
Why This Matters
The potential compromise in sterility assurance level could affect the safety of surgical procedures involving these kits.
Source
FDA recall Z-2110-2026 (Class II, ongoing), initiated January 7, 2026.
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 (1,777 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.