The Recall Desk
ModerateFDA (Devices)·Z-2061-2019·Announced 2019-07-31

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.

What this means for you

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
Category
Medical Device — Breastfeeding Equipment
Hazard

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

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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