Medline Industries Recalls PPE Kits Due to Potential Sterility Issues

Source: FDA · United States

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Medline Industries, LP has voluntarily recalled over 7,500 PPE kits because of equipment calibration issues that may compromise the sterility of the medical devices.

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 "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 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 its PPE kits after identifying calibration issues with equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the identified calibration errors have the potential to impact the sterility assurance level (SAL) of the devices, meaning their sterility cannot be guaranteed.

Which Products Are Affected

The recall affects Medline Convenience Kits: PPE KIT, specifically Model Number: DYK1011945P. Approximately 7,575 units are included in this recall. The products were distributed worldwide and nationwide across the United States.

Affected lot numbers include:

  • 25IFA006
  • 24GFA027, 24FFA115, 24BFA115
  • 23LFA050, 23GFA079, 23EFA070, 23EFA007, 23DFA024, 23CFA070, 23BFA124, 23BFA006, 23AFA090, 23AFA049
  • 22LFA068, 22JFA111, 22IFA036, 22DFA081, 22CFA086, 22BFA066
  • 21KFA114, 21JFA139, 21JFA039, 21IFA100, 21HFA112, 21GFA025, 21FFA074, 21EFA047, 21BFA109

UDI-DI numbers associated with these units are 10884389389973 (each) and 40884389389974 (case).

What You Should Do

Consumers and healthcare providers should immediately check their inventory for the affected model and lot numbers listed above. Medline Industries, LP notified customers of the issue via letter starting in January 2026. If you possess any of the recalled units, follow the instructions provided in the firm's notification letter regarding the return or disposal of the product.

Why This Matters

Sterility is critical for personal protective equipment used in medical settings. If the sterility assurance level is compromised, there is an increased risk of infection or contamination for both healthcare workers and patients.

Source

Information provided by the FDA under Recall Number Z-1408-2026.

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 has voluntarily recalled over 7,500 PPE kits because of equipment calibration issues that may compromise the sterility of the medical devices.
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.