Medline Industries Recalls 154,427 Convenience Kits Over Sterility Concerns
Medline Industries, LP is recalling over 154,000 medical convenience kits due to equipment calibration issues that may compromise the sterility of the devices.
What this fda recalls alert 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 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 an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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 various medical convenience kits due to calibration issues with equipment used during the sterilization and packaging process. While all affected 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 a total of 154,427 units distributed nationwide in the U.S. and worldwide. The products include a vast range of Medline Convenience Kits used in various medical procedures. Affected model series include:
- ACC Series: Including Model Numbers ACC010326, ACC010326A, ACC010475, ACC010542, ACC010543, ACC010722, and ACC010896.
- CDS Series: Including Model Numbers CDS860063U, CDS860066T, CDS981795G, CDS982414N, CDS982823R, CDS982895I, CDS983069F, CDS983376S, CDS983611N, CDS983653K, CDS983653L, CDS983653M, CDS983908Q, CDS984244I, CDS985431M, and CDS985557L.
- DYK/DYKM/DYNJ Series: Hundreds of surgical and procedure kits including Prep Kits, GI Packs, Maternity Kits, Robotics Urology Kits, and Ortho Total Shoulder Kits.
- EDUC and MNS Series: Including EDUC05000A, EDUC05041, MNS13935, and MNS3710A.
Specific lot numbers and UDI-DI information for these products are extensive, covering production ranges from 2020 through 2025. Official recall number: Z-1399-2026.
What You Should Do
Medline Industries notified affected customers and distributors via a formal letter initiated on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the model and lot numbers listed in the recall notification. Affected products should be quarantined and handled according to the specific instructions provided in the firm's notification letter.
Why This Matters
This recall is significant because medical kits must maintain a specific Sterility Assurance Level to ensure patient safety. Equipment calibration issues could result in non-sterile products being used in surgical or clinical environments, potentially leading to patient infections or other health complications.
Source
Information provided by the FDA.
Source: FDA Official Notice