Medline Industries Recalls Sterile Resuture Packs Due to Potential Packaging Seal Defect
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Medline Industries, LP has initiated a voluntary recall of 216 Sterile Resuture Packs because included swabsticks may have compromised packaging seals, affecting sterility.
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 issued a voluntary, firm-initiated recall for specific medical convenience kits. The recall was prompted by a discovery that BD ChloraPrep Triple Swabsticks included within the kits may exhibit an open seal on the applicator packaging. This defect was identified by BD and affects the integrity of the sterile components within the Medline kits.
Which Products Are Affected
The recall involves Medline medical convenience kits distributed nationwide across the United States. A total of 216 kits are included in this action.
- Product Name: Medline medical convenience kits packaged as: STERILE RESUTURE PACK
- Kit SKU: DYNDL1980A
- UDI/DI: 10195327379292
- Lot Number: 25EBJ785
- Recall Number: Z-1335-2026
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBJ785). Medline Industries has initiated notification through multiple channels, including email, fax, letter, and telephone. Affected products should be quarantined and handled according to the instructions provided by Medline Industries, LP. For further information regarding returns or replacements, contact Medline Industries directly at their Northfield, IL headquarters.
Why This Matters
An open seal on medical components intended to be sterile, such as swabsticks, can lead to contamination. Using non-sterile components in a resuture pack poses a risk of infection to patients during medical procedures.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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