The Recall Desk

Manufacturer

Medela Inc

4 recalls in our database name Medela Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2026-07-08

Of the 4 recalls from Medela Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-2645-2026·2026-07-08

    Medela ENFit ExSet Enteral Extension Set Connector Compatibility Issue

    Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.

    Product
    Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Componen
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0773-2020·2020-01-08

    Medela Invia Foam Dressing Kit Recalled for Packaging Defects

    Medela Inc is recalling Invia Foam Dressing Kits with FitPad because holes in the sterile packaging may compromise sterility.

    Product
    Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2061-2019·2019-07-31

    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.

    Product
    Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2018·2018-08-01

    Medela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error

    Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.

    Product
    Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Medela

Country
Switzerland
Founded
1961

Official website

Source: Wikidata (Q1916070), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.