Medline Industries Recalls Mercy Circumcision Trays Due to Compromised Packaging

Source: FDA · United States

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Medline Industries, LP has issued a voluntary recall for 168 Mercy Circumcision Trays because of potential open seals on included BD ChloraPrep Triple Swabsticks.

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 recall of specific medical convenience kits. The recall was triggered after it was determined that BD ChloraPrep Triple Swabsticks included within the kits may exhibit an open seal on the packaging of the applicators. This defect was identified by BD, the manufacturer of the swabsticks.

Which Products Are Affected

The recall affects the Medline medical convenience kit packaged as the MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B.

Specific details for the affected units include:

  • Quantity: 168 units
  • Lot Number: 25EBC648
  • UDI/DI: 10653160990666
  • Recall Number: Z-1336-2026
  • Distribution: Nationwide across the United States

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBC648). Medline has initiated notification through various methods, including email, fax, letter, and telephone. If you possess the affected kits, you should follow the instructions provided in the firm's notification for the return or disposal of the product. For additional information, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

An open seal on sterile medical components like swabsticks can compromise the sterility of the device. Using non-sterile components in a medical procedure like circumcision poses a potential risk of infection to the patient.

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 has issued a voluntary recall for 168 Mercy Circumcision Trays because of potential open seals on included BD ChloraPrep Triple Swabsticks.
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.