Medline Recalls Suture Removal Trays Due to Potential Compromise of Sterile Packaging

Source: FDA · United States

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Medline Industries, LP has initiated a voluntary recall of 2,448 Suture Removal Trays because internal BD ChloraPrep Triple Swabsticks may have open seals, compromising sterility.

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

This notice was issued by FDA on February 25, 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 Class II recall for specific medical convenience kits. The recall was prompted by a determination that BD ChloraPrep Triple Swabsticks, which are included as components within the kits, may exhibit an open seal on the applicator packaging. This defect was identified by the component manufacturer, BD.

Which Products Are Affected

The recall involves Medline medical convenience kits distributed nationwide across the United States. A total of 2,448 kits are included in this action.

  • Product Name: Medline SUTURE REMOVAL TRAY
  • Kit SKU: DYNDR1277A
  • UDI/DI: 10195327379308
  • Lot Number: 25EBO576
  • Recall Number: Z-1332-2026

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBO576). Medline Industries, LP has initiated notification to customers through various channels, including email, fax, letter, and telephone. If you possess the affected product, follow the specific instructions provided in the firm's notification regarding the return or disposal of the kits. For further inquiries, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

An open seal on medical components intended to be sterile, such as the ChloraPrep swabsticks used in these trays, can lead to contamination. Using non-sterile components during medical procedures like suture removal increases the risk of infection for patients.

Source

This information is based on official recall data 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 has initiated a voluntary recall of 2,448 Suture Removal Trays because internal BD ChloraPrep Triple Swabsticks may have open seals, compromising 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 "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.