McHenry, IL, United States
Medela Inc recalls
4 recalls recorded since 2018, most recently on 5 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 June 2026
- Reason
- May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
- Distribution
- US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2645-2026
- 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
Terminated Class II Medical devices
- Recall started
- 2 December 2019
- Terminated
- 2 November 2020
- Reason
- Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
- Distribution
- AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0773-2020
- 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 dependin
Terminated Class III Medical devices
- Recall started
- 5 December 2018
- Terminated
- 25 August 2020
- Reason
- The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2061-2019
- Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Terminated Class II Medical devices
- Recall started
- 7 February 2018
- Terminated
- 4 December 2018
- Reason
- Device may display a battery missing error.
- Distribution
- US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX. Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2528-2018
- 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 Pr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.