Medline C-Section Kits Recall Due to Sterility Issues

Source: FDA · United States

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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.