Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093

Recall Insight

This FDA Drug action (record #D-0304-2018) was formally reported on February 7, 2018, with the manufacturer initiating the action on September 21, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 88 cases units are affected.

The documented reason for this recall is: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Distribution data in the federal record shows the product reached: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.