Class III — Medela Inc
| Recalling firm | MEDELA AG |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. |
| Product | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 |
| Quantity | 665,600 lids (6,656 cases) |
| Distribution | 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 in AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI |
| Initiated | 2018-12-05 |
| Classified | 2019-07-23 |
| Terminated | 2020-08-25 |
| Recall number | Z-2061-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Medela Inc (Z-2061-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81779/
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