Medela Breast Milk Transfer Lid Recall for Packaging Sterility Concerns
Medela Inc is recalling 665,600 breast milk transfer lids because packaging breaches may compromise sterility, even if the packaging appears intact.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of the product is not likely to cause adverse health consequences, aligning with the Moderate severity level for low-risk contamination or precautionary recalls.
Plain-English summary
Medela Inc is recalling 665,600 breast milk transfer lids (Model 90003S-100) used with oral syringe connectors. The recall involves 6,656 cases of the product.
The recall is being conducted because the sterility of the lids may be compromised due to a potential breach in the packaging, even though the packaging may appear intact. The affected lot codes are 441113, 441825, 441965, 442099, 442188, 442494, 442612, 443265, 443557, 444054, 444317, 445260, 445310, 445470, 445678, 446402, 446518, 446916, 447447, 447470, and 447789.
The product was distributed nationwide in Illinois, Missouri, Nebraska, Ohio, Rhode Island, Tennessee, Texas, and Virginia, as well as internationally in Canada. It was also distributed to internal Medela locations and sales representatives in California, Colorado, Illinois, Louisiana, North Carolina, New Jersey, Nevada, Pennsylvania, South Carolina, Tennessee, and Texas, and to domestic hospitals in numerous states including Alabama, Arizona, California, Florida, Georgia, New York, and Washington. Consumers and healthcare facilities should stop using the affected lids and contact Medela Inc for further instructions.
The recalled product
- Product
- Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
- Manufacturer
- Medela Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: 90003S-100
- Lot codes: 441113
- 441825
- 441965
- 442099
- 442188
- 442494
- 442612
- 443265
- 443557
- 444054
- 444317
- 445260
- 445310
- 445470
- 445678
- 446402
- 446518
- 446916
- 447447
Distribution
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