Medline Industries Recalls 82,597 Surgical Convenience Kits Over Sterility Concerns
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Medline Industries, LP has initiated a voluntary recall of over 82,000 surgical convenience kits due to equipment calibration issues that may have compromised product 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 "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 Class II recall of various surgical convenience kits. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the devices.
Which Products Are Affected
The recall involves 82,597 units distributed nationwide in the United States and worldwide. Affected products include a wide range of Medline Convenience Kits, including but not limited to:
- Major and Minor Laparotomy CDS: Model numbers CDS860015U, CDS860015V, CDS860015W, CDS860015X, CDS860016P, CDS860016Q, CDS860016R, CDS860016S.
- Robotic and Laparoscopy Kits: Model numbers CDS984244J, CDS985422I, CDS985429L, CDS985558N, CDS985558O.
- Specialized Surgical Bundles (DYKMBNDL Series): Including kits for Gastric Bypass, Cysto, Endo, General Surgery Exlap, Urology Prostate, Penile Repair, and Thoracic Robotic Lobectomy.
- Specific Lot Numbers: The recall covers a vast range of lot numbers beginning with prefixes such as 21, 22, 23, 24, and 25 (e.g., 21LBT172, 25EBQ940, 24CDA326).
Official Recall Number: Z-1395-2026.
What You Should Do
Medline Industries notified affected customers via a formal letter. Healthcare providers and distributors should immediately check their inventory for the model and lot numbers listed in the recall. Affected products should be quarantined and not used in clinical settings. For instructions on returning products or obtaining refunds, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
Sterility is a critical requirement for surgical instruments and convenience kits. If the Sterility Assurance Level is compromised, there is an increased risk of patient infection during surgical procedures. This recall ensures that potentially non-sterile equipment is removed from medical environments to protect patient health.
Source
This information is provided by the FDA and is based on official recall event ID 98329.
Original source: FDA Official Notice ↗
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