Medline Convenience Kits Recall Due to Sterility Issue
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 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 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 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 ↗
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 (1,360 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.