Medline Industries Recalls 9,051 Convenience Kits Over Sterility Assurance Concerns
Medline Industries, LP has initiated a voluntary recall of various medical convenience kits due to equipment calibration issues that could impact the sterility of the devices.
What Happened
Medline Industries, LP has identified issues related to the calibration of equipment used to sterilize and package various medical convenience kits. While all affected products were exposed to validated sterilization and packaging cycles, the identified calibration errors have the potential to impact the sterility assurance level (SAL) of the products. This voluntary recall was initiated by the firm on January 7, 2026.
Which Products Are Affected
The recall affects 9,051 units across 70 different types of Medline Convenience Kits. These products were distributed nationwide in the United States and worldwide. Affected models include, but are not limited to:
- CHP Cochlear Supplement CDS: Models CDS983069G, CDS983069I
- Bronchoscopy Setup Kits: Models DYKE1456D, DYKE1955
- ENT Head and Neck Kits: Models DYKMBNDL156, DYKMBNDL156A, DYKMBNDL156B, DYKMBNDL196, DYNJ41169, DYNJ67208
- Thyroidectomy and Excision Kits: Models DYKMBNDL66A, DYKMBNDL66B, DYKMBNDL88A, DYKMBNDL88B, DYKMBNDL88C
- Laryngectomy Kits: Models DYKMBNDL174, DYKMBNDL174A, DYKMBNDL174B
- Specialized Packs: Nasalplasty (DYNJ27320V), Sinus Packs (DYNJ17005I, DYNJ88498), and Mediastinal Packs (PHS393087007C)
Specific lot numbers and UDI-DI information for each of the 70 affected models are listed in the official FDA enforcement report under recall number Z-1394-2026.
What You Should Do
Medline Industries notified affected customers via a formal letter. 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 not used in clinical settings. For information regarding returns or refunds, customers should contact Medline Industries, LP directly at their Northfield, IL headquarters.
Why This Matters
Sterility is critical for medical devices used in surgical and diagnostic procedures. A failure in sterility assurance can increase the risk of patient infections and other serious health complications during or after medical interventions.
Source
This information is provided by the FDA under Recall Event ID 98329.
Source: FDA Official Notice