Medline Industries Recalls 30,958 Convenience Kits Over Sterility Concerns
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Medline Industries, LP is recalling over 30,000 medical convenience kits, including cardiac and angiography packs, due to sterilization equipment calibration issues.
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 "high" 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 various medical convenience kits due to 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.
Which Products Are Affected
The recall affects 30,958 units distributed nationwide in the United States and worldwide. The recall involves 48 different types of convenience kits, including but not limited to:
- OR Arteriogram: Model CDS985094F
- CVC Bundle Kits: Models ECVC6225A, ECVC7265A
- Cath Lab Packs: Models DYNJ30955I, DYNJ31773K, DYNJ68633, DYNJ81197B/C/D/F/G, DYNJ83089
- Angiography Packs: Models DYNJ0954970I, DYNJ43415D, DYNJ43415F, DYNJ53129D
- Surgical Oncology Kits: Model DYKMBNDL153
- Vein Procedure Kits: Model DYNDA2076C
- Cardiac Cath Packs: Models DYNJ0150605AC, DYNJ19946M, DYNJ35300M, DYNJ39066B, DYNJ47370B, DYNJ58048C
Specific lot numbers and UDI-DI information for each affected model are associated with official recall number Z-1389-2026.
What You Should Do
Medline Industries initiated the recall on January 7, 2026, and began notifying customers via an initial firm notification letter. Healthcare facilities and providers should immediately review their inventory for the affected model and lot numbers. Consumers and medical staff should follow the specific instructions provided in the Medline notification letter regarding the return or disposal of these products.
Why This Matters
Sterility is essential for medical devices used in invasive surgical and catheterization procedures. A potential failure to meet sterility assurance levels increases the risk of patient infection and other serious health complications.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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