Medela Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
55
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0773-2020Class IIInvia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit December 2, 2019
Z-2061-2019Class IIIBreast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100December 5, 2018
Z-2528-2018Class IIInvia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure WFebruary 7, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K253149Motion InBra (YM-8801) wearable breast pumpFebruary 13, 2026
K253498Pump In Style® Pro+January 22, 2026
K251377Magic InBraSeptember 18, 2025
K232608Duo Hands-free Breast PumpApril 12, 2024
K223388Invia® Integrated DressingJuly 7, 2023
K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemJuly 26, 2022
K210759Solo, Swing MaxiAugust 11, 2021
K200508Pump In StyleJune 15, 2020
K191653Freestyle FlexOctober 17, 2019
K182191Invia Abdominal Dressing KitFebruary 1, 2019
K180415Invia White Foam NPWTNovember 2, 2018
K181937Pump In Style Advanced, Advanced Personal Double BreastpumpOctober 16, 2018
K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia MotMay 9, 2018
K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing KitApril 6, 2017
K161811Medela Low Dose Enteral SyringeFebruary 15, 2017
K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative PressurDecember 1, 2016
K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector sOctober 28, 2016
K153663Vario 8/18/ciMay 18, 2016
K151632Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump November 5, 2015
K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit LargeOctober 7, 2015