DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08

Recall Insight

This FDA Devices action (record #Z-1417-2020) was formally reported on March 11, 2020, with the manufacturer initiating the action on February 4, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Deroyal Industries, Inc. Lafollette is listed as the recalling firm, operating out of La Follette, TN. Federal records indicate 2100 units units are affected.

The documented reason for this recall is: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Distribution data in the federal record shows the product reached: US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange. 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 and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. 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 6 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.