Medela Inc
FDA Regulatory Profile
Medela Inc appears in FDA public data with 4 recalls, 56 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2645-2026, Class II) was initiated on June 5, 2026. Its most recent 510(k) clearance was granted on April 10, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 56
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2645-2026 | Class II | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060 | June 5, 2026 |
| Z-0773-2020 | Class II | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit | December 2, 2019 |
| Z-2061-2019 | Class III | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 | December 5, 2018 |
| Z-2528-2018 | Class II | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure W | February 7, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253510 | Freestyle Mini Hands-free | April 10, 2026 |
| K253149 | Motion InBra (YM-8801) wearable breast pump | February 13, 2026 |
| K253498 | Pump In Style® Pro+ | January 22, 2026 |
| K251377 | Magic InBra | September 18, 2025 |
| K232608 | Duo Hands-free Breast Pump | April 12, 2024 |
| K223388 | Invia® Integrated Dressing | July 7, 2023 |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | July 26, 2022 |
| K210759 | Solo, Swing Maxi | August 11, 2021 |
| K200508 | Pump In Style | June 15, 2020 |
| K191653 | Freestyle Flex | October 17, 2019 |
| K182191 | Invia Abdominal Dressing Kit | February 1, 2019 |
| K180415 | Invia White Foam NPWT | November 2, 2018 |
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | October 16, 2018 |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Mot | May 9, 2018 |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kit | April 6, 2017 |
| K161811 | Medela Low Dose Enteral Syringe | February 15, 2017 |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressur | December 1, 2016 |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector s | October 28, 2016 |
| K153663 | Vario 8/18/ci | May 18, 2016 |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump | November 5, 2015 |