FDA Recalls medium

Medline Surgical Gowns Recall Issued Over Sterility Concerns

Source: FDA · United States

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, LP is recalling over 70 million units of surgical gowns due to potential sterility issues from equipment calibration problems.

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 initiated a voluntary recall of Medline Surgical Gowns after identifying calibration issues with sterilization equipment. The issues have the potential to impact the sterility assurance level (SAL) of the products, though all products were exposed to validated sterilization and packaging cycles.

Which Products Are Affected

The recall covers Medline Surgical Gowns under numerous model numbers including DYNJP2001, DYNJP2001S, DYNJP2002, DYNJP2002S, DYNJP2002SL, DYNJP2003, DYNJP2003S, DYNJP2003SL, DYNJP2004, DYNJP2004S, DYNJP2005, DYNJP2005S, DYNJP2009, DYNJP2009S, DYNJP2101, DYNJP2101S, DYNJP2102, DYNJP2102S, DYNJP2103, DYNJP2103S, DYNJP2103SL, DYNJP2201, DYNJP2201S, DYNJP2202, DYNJP2202S, DYNJP2203, DYNJP2203S, DYNJP2204, DYNJP2204S, DYNJP2205, DYNJP2205S, DYNJP2206, DYNJP2206S, DYNJP2301P, DYNJP2302P, DYNJP2303P, DYNJP2306P, DYNJP2307P, DYNJP2308P, DYNJP2361P, DYNJP2362P, DYNJP2363P, DYNJP2366P, DYNJP2367P, DYNJP2368P, DYNJP2369P, DYNJP2401, DYNJP2402, DYNJP2403, DYNJP2501, DYNJP2502, DYNJP2503, DYNJP2602, DYNJP2701, DYNJP2702, DYNJP2703, DYNJP2704, DYNJP2705, DYNJP2706, DYNJP2707, DYNJP2708, DYNJP2709, DYNJP2712, DYNJP2715, DYNJP2725, DYNJP2726, DYNJP2727, DYNJP2728, DYNJP2729, DYNJP2801, DYNJP2802, DYNJP2803, DYNJP2804, DYNJP2805, DYNJP2806, DYNJP2807, DYNJP2808, DYNJP2809, DYNJPBRGR1 and associated variants. A total of 70,376,042 units are affected across specific lot numbers. The recall number is Z-2129-2026. Distribution was nationwide in the US and worldwide.

What You Should Do

Consumers and healthcare facilities should check product lots against the recall list and follow instructions from Medline Industries, LP for returns or further guidance. Contact the recalling firm for additional information.

Why This Matters

Class II recalls address situations where exposure to a violative product may cause temporary or medically reversible adverse health consequences.

Source

FDA recall database, recall number Z-2129-2026. Agency: FDA. Recalling firm: Medline Industries, LP, Northfield, IL.

Original source: FDA Official Notice ↗

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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 (2,082 characters here).

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Similar severity timing

Same severity (medium) notices issued closest in time to May 26, 2026.

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
Medline Industries, LP is recalling over 70 million units of surgical gowns due to potential sterility issues from equipment calibration problems.
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.

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