Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

Recall Insight

This FDA Devices action (record #Z-2061-2019) was formally reported on July 31, 2019, with the manufacturer initiating the action on December 5, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Medela Inc is listed as the recalling firm, operating out of McHenry, IL. Federal records indicate 665,600 lids (6,656 cases) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. Distribution data in the federal record shows the product reached: Nationwide distribution in IL, MO, NE, OH, RI, TN, TX, VA. International distribution in Canada Internal Medela and sales reps located in CA, CO, IL, LA, NC, NJ, NV, PA, SC, TN, TX Domestic Hospitals located …. 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 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 7 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.