Medline Industries Recalls Surgical and Medical Convenience Kits Over Sterility Concerns
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Medline Industries, LP is recalling 7,725 units of various medical convenience kits due to equipment calibration issues that may have compromised the sterility of the products.
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 initiated a voluntary Class II recall for several types of medical convenience kits. The company identified issues related to the calibration of equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the affected products.
Which Products Are Affected
A total of 7,725 units are included in this recall, distributed nationwide in the United States and worldwide. The recall affects 31 specific convenience kit models, including:
- Robotic Surgery/Urology Kits: CDS982407N, DYKMBNDL109A, DYKMBNDL116A, DYKMBNDL116G, DYNJ04135B
- GYN and Lithotomy Kits: CDS985431K, CDS985431O, DYNJ04382J, DYNJ47713A, DYNJ55377D, DYNJ80765C, DYNJ83475, DYNJ902711L, DYNJ902711N, DYNJT6424
- D&C (Dilation and Curettage) Packs: DYNJ0665843C, DYNJ22567G, DYNJ22567J, DYNJ41272B, DYNJ41272C, DYNJ67214D, DYNJ67214F, DYNJ67214G, DYNJ67214I, DYNJ87468, DYNJ900465C, DYNJ900465D, DYNJ900465F, DYNJ906947C
- Other Specialized Packs: OB PACK (DYNJ42884) and ANTERIOR CERVICAL-LF (DYNJ58344)
Specific lot numbers and UDI-DI information for each model are detailed in the official FDA enforcement report under recall number Z-1419-2026.
What You Should Do
Medline Industries notified affected customers via letter starting January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed in the recall. Affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information, customers can contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.
Why This Matters
Sterility is critical for medical devices used in surgical and clinical procedures. If the sterility assurance level is compromised, there is an increased risk of patient infection or other complications during medical interventions.
Source
FDA Recall Notice - Recall Event ID 98329.
Original source: FDA Official Notice ↗
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