Medline Convenience Kits Recall Due to Sterility Issue

Source: FDA · United States

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Medline Industries is recalling 160,980 units of convenience kits for spinal, hip, and knee procedures due to potential sterility concerns 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 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 numerous Medline Convenience Kits including SPINAL CDS (models CDS940087AG, CDS940087AI), TOTAL HIP CDS-LF (models CDS980832Q, CDS980832R, CDS980832S), TOTAL KNEE CDS-LF (models CDS980833Q, CDS980833R), TOTAL HIP PROCEDURE (models CDS980865V, CDS980865W), and many additional models listed in the recall. A total of 160,980 units distributed nationwide in the United States and worldwide are affected. The recall number is Z-2114-2026. Full list of model numbers, UDI-DIs, and lot numbers available via FDA.

What You Should Do

Consumers and healthcare facilities should follow guidance from the recalling firm regarding the affected devices.

Why This Matters

The potential impact on sterility assurance level of surgical kits used in spinal, hip, and knee procedures could affect infection control in medical settings.

Source

FDA Recall Z-2114-2026 - Medline Industries, LP, Class II recall 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 is recalling 160,980 units of convenience kits for spinal, hip, and knee procedures due to potential sterility concerns 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.