Medela recalls

Medela has 4 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 8 Jul 2026. 1 is still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls4since 2018

Last 12 months1reported

Class I00% of total

Ongoing1latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 1 0Aug 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why medela is recalled

Device Malfunction250%
Sterility250%

Product types

By year

2026125%
2020125%
2019125%
2018125%

Ongoing medela recalls

1 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	ENFit ExSet Strl 60 PV EN recalled by Medela	Medela	Device Malfunction	18 states

All medela recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	ENFit ExSet Strl 60 PV EN recalled by Medela	Medela	Device Malfunction	18 states
8 Jan 2020Device	CLASS II	Invia Foam Dressing Kit with FitPad - X-Large recalled by Medela	Medela	Sterility	16 states
31 Jul 2019Device	CLASS III	Breast Milk Transfer Lid for use with Oral Syringe Connectors recalled	Medela	Sterility	Nationwide
1 Aug 2018Device	CLASS II	Invia Motion Negative Pressure Wound Therapy System recalled by Medela	Medela	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.