Medline Industries Recalls Mercy Circumcision Trays Due to Compromised Packaging
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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 April 6, 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 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 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 ↗
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