Medline Industries Recalls Drape Pack-Choice Convenience Kits Over Sterility Concerns

Source: FDA · United States

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Medline Industries, LP is recalling 72 units of its Drape Pack-Choice convenience kits because calibration issues with sterilization equipment may have compromised the products' sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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.

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What Happened

Medline Industries, LP has initiated a voluntary recall of specific Medline Convenience Kits after identifying calibration issues with the equipment used to sterilize and package the devices. Although the products were exposed to validated sterilization and packaging cycles, the firm determined that the calibration errors have the potential to impact the sterility assurance level (SAL) of the recalled units.

Which Products Are Affected

The recall involves the following medical device:

  • Product Name: Medline Convenience Kits: DRAPE PACK-CHOICE
  • Model Number: DYNJ63118A
  • Lot Number: 25ABV005
  • UDI-DI: 10195327644291 (each); 40195327644292 (case)
  • Quantity: 72 units
  • Recall Number: Z-1406-2026

These units were distributed nationwide within the United States and through worldwide distribution channels.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for the affected lot number (25ABV005). Affected products should be quarantined and should not be used in clinical settings. Medline Industries began notifying customers of the issue via letter on January 7, 2026. For information regarding the return or replacement of these kits, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Compromised sterility in medical devices like drape packs can lead to a significantly increased risk of infection for patients during surgical or medical procedures. Maintaining a high sterility assurance level is critical for patient safety.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 72 units of its Drape Pack-Choice convenience kits because calibration issues with sterilization equipment may have compromised the products' sterility.
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 "high" severity. Take precautions and monitor for updates.
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.