Medela Inc recalls
Every recall we track for Medela Inc — 4 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for Medela Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Medela Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medela Inc recalls
4 shown- Lower riskMedical device
Medela Inc recalls Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086
Medela recalls ENFit ExSet Strl 60 2.0ml PV 1ct EN due to incompatible connectors that may cause delays in feeding or medication delivery. Affected units have model ENF060182LD or 101033086.
MedelaJun 5, 2026 - Lower riskMedical device
Medela Inc recalls Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists
Medela recalls Invia Foam Dressing Kit with FitPad X-Large (3 pcs) SKU #0876224 due to potential holes in sterile packaging. This could compromise sterility during medical use. Affected units were sold with specific expiration dates.
MedelaDec 2, 2019 - Lower riskMedical device
Medela Inc recalls Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Medela recalls breast milk transfer lids (model 90003S-100) due to potential packaging breaches that could compromise sterility. Affected units have specific lot codes.
MedelaDec 5, 2018 - Lower riskMedical device
Medela Inc recalls Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model
Medela recalls Invia Motion Negative Pressure Wound Therapy systems with battery missing error display. Affected models include Endure (087.4010) and 15/60-day therapy versions. No remedy specified in recall notice.
MedelaFeb 7, 2018
Medela Inc recall questions
How many recalls has Medela Inc had?
4 recalls from Medela Inc are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Medela Inc recall?
Medela Inc recalls Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086, dated Jun 5, 2026. Every Medela Inc recall is listed on this page, newest first.
What should I do if I have a recalled Medela Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medela Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.