Medline Convenience Kits Recall Issued by FDA
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Medline Industries, LP is recalling 4,064 units of convenience kits distributed nationwide due to potential sterility assurance issues from equipment calibration problems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 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 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 initiated a voluntary recall after identifying calibration issues with equipment used to sterilize and package the devices. All products underwent validated sterilization cycles, but the calibration problems may affect the sterility assurance level.
Which Products Are Affected
The recall covers 13 Medline Convenience Kit models with multiple lot numbers totaling 4,064 units distributed nationwide in the United States and worldwide. Affected models include:
- KIT SURG ONC EXCISION BREAST (DYKMBNDL84A)
- KIT SURG ONC EXPLORATORY LAP (DYKMBNDL87A)
- CT BIOPSY TRAY (DYNDH1143C)
- BIOPSY SPECIALS PACK (DYNDH1873, DYNDH1934)
- BREAST BIOPSY PACK (DYNJ17489I)
- C T BIOPSY TRAY-LF (DYNJ17558D)
- RIGHT HEART BIOPSY TRAY (DYNJ19063K)
- VOR PACK-LF (DYNJ48539, DYNJ48539A)
- IR BIOPSY PACK (DYNJ59897B)
- BREAST PACK (DYNJ82998)
- LIVER BIOPSY KIT (DYNJ910654)
Specific UDI-DI and lot numbers are listed in FDA recall Z-2095-2026. This is a Class II recall.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
The potential impact on sterility assurance level could affect the safety of surgical and biopsy kits used in medical procedures.
Source
FDA Enforcement Report, recall number Z-2095-2026, initiated January 7, 2026.
Original source: FDA Official Notice ↗
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