Medline Industries Recalls Over 70 Million Surgical Gowns Due to Sterility Concerns
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 more than 70 million surgical gowns nationwide due to equipment calibration issues that may have compromised the sterility of the products.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references National. 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 several models of surgical gowns due to issues related to the calibration of equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization and packaging cycles, the identified calibration defects have the potential to impact the sterility assurance level (SAL) of the gowns.
Which Products Are Affected
The recall involves approximately 70,376,042 units distributed nationwide across the United States and worldwide. Affected products include various Medline Surgical Gowns under the following model series:
- Standard Gowns: DYNJP2001, DYNJP2003, DYNJP2004, DYNJP2005, DYNJP2009
- SIRUS Series: DYNJP2001S, DYNJP2002S, DYNJP2002SL, DYNJP2003S, DYNJP2003SL, DYNJP2004S, DYNJP2005S, DYNJP2009S, DYNJP2101S, DYNJP2102S, DYNJP2103S, DYNJP2201S, DYNJP2202S, DYNJP2203S, DYNJP2204S, DYNJP2205S, DYNJP2206S, DYNJP2401, DYNJP2402, DYNJP2403, DYNJP2501, DYNJP2502, DYNJP2503
- ECLIPSE Series: DYNJP2002, DYNJP2101, DYNJP2102, DYNJP2103, DYNJP2201, DYNJP2202, DYNJP2203, DYNJP2204, DYNJP2205, DYNJP2206
- PREVENTION PLUS Series: DYNJP2301P, DYNJP2302P, DYNJP2303P, DYNJP2306P, DYNJP2307P, DYNJP2308P
- ORBIS Series (Level 3): DYNJP2361P, DYNJP2362P, DYNJP2363P, DYNJP2366P, DYNJP2367P, DYNJP2368P, DYNJP2369P
Specific lot numbers and UDI-DI codes for these models are included in the official recall documentation. The recall is identified by FDA Recall Number Z-1424-2026.
What You Should Do
Medline Industries, LP began notifying affected customers via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model numbers and lot numbers. If you have these products in stock, follow the specific instructions provided in the firm's notification letter regarding the return or disposal of the gowns.
Why This Matters
Surgical gowns are critical for maintaining a sterile field during medical procedures. A potential failure in the sterility assurance level increases the risk of infection for both patients and healthcare providers, though this recall is classified as Class II, indicating the health risk is not immediately life-threatening.
Source
Information provided by the FDA under Recall Number Z-1424-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.