Medline Surgical Drapes Recall Issued for Sterility Concerns
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Medline Industries is recalling over 14.9 million surgical drapes due to potential issues with sterilization equipment calibration that may affect sterility assurance levels.
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 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. This is an ongoing Class II recall initiated voluntarily by the firm.
Which Products Are Affected
The recall affects 54 Medline Surgical Drape models including: SHEET,DRAPE,40X58,STERILE (DYNJP2410); DRAPE,SHEET,ECONOMY,40X58",ST,20/CS (DYNJP2411); SHEET,DRAPE, 40X70,STERILE (DYNJP2412); and dozens of additional models such as DYNJP2412T, DYNJP2414, DYNJP2414R, DYNJP2414UG, DYNJP2416, DYNJP2417, DYNJP2418, DYNJP2419, DYNJP2462, DYNJP2491, DYNJP2492, DYNJP2498, DYNJP3003, DYNJP3003UG, DYNJP3008, DYNJP3008UG, DYNJP3009, DYNJP3101, DYNJP3102A, DYNJP3102UG, DYNJP3103, DYNJP3109, DYNJP4002, DYNJP4003, DYNJP4106, DYNJP4119, DYNJP4215, DYNJP6002, DYNJP6006, DYNJP7001, DYNJP7003, DYNJP8002, DYNJP8002UG, DYNJP8003, DYNJP8003UG, DYNJP8005, DYNJP8005UG, DYNJP8201, DYNJP8201UG, DYNJP8211, DYNJP8301, DYNJP8304A, DYNJP8304UG, DYNJP8412, DYNJP8412UG, DYNJP8414, DYNJP9001, DYNJP9103, MED901, MED902, and MED903. A total of 14,927,765 units are affected. Specific lot numbers and UDI-DI codes are listed in the recall notice. Distribution was US nationwide and worldwide.
What You Should Do
The recall is voluntary and ongoing. No specific consumer action steps are provided in the recall notice.
Why This Matters
The potential impact on sterility assurance level of surgical drapes used in medical procedures represents a medium-risk defect that could affect device performance.
Source
FDA recall number Z-2128-2026. Recalling firm: Medline Industries, LP, 3 Lakes Dr, Northfield, IL 60093-2753.
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 (1,866 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.