MEDELA, INC.

PUMP IN STYLE

FDA Adverse Event

Malfunction ·MEDELA, INC·Product code HGX·June 4, 2001

MEDELA PUMP AND SAVE BREAST PUMP BAGS

FDA Adverse Event

Malfunction ·MEDELA, INC.·Product code HGY·April 24, 2009

PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

FDA Adverse Event

Malfunction ·MEDELA, INC.·Product code HGX·April 17, 2013

AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.

FDA Recall

Terminated ·Medela Inc·Product code OHH·April 4, 2011

PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

FDA Adverse Event

Malfunction ·MEDELA, INC.·Product code HGX·July 30, 2013

Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118

FDA Recall

Terminated ·Medela Inc·Product code MCY·July 27, 2011

Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.

FDA Recall

Terminated ·Medela Inc·Product code HFS·May 18, 2011

Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article # 67099S

FDA Recall

Terminated ·Medela Inc·Product code HGX·August 6, 2010

Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.

FDA Recall

Terminated ·Medela Inc·Product code HGX·January 10, 2011

Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67116S

FDA Recall

Terminated ·Medela Inc·Product code HGX·August 6, 2010

Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S

FDA Recall

Terminated ·Medela Inc·Product code HGX·August 6, 2010

Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;

FDA Recall

Terminated ·Medela Inc·Product code HGX·March 15, 2010

Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67093S

FDA Recall

Terminated ·Medela Inc·Product code HGX·August 6, 2010

FREESTYLE BREAST PUMP

FDA Adverse Event

Injury ·MEDELA, INC.·Product code HGX·June 4, 2013

MINIELECTRIC; LACTINA

FDA Adverse Event

Death ·MEDELA, INC.·Product code HGX·April 25, 2005

PUMP IN STYLE (ITEM # UNK)

FDA Adverse Event

Malfunction ·MEDELA, INC.·Product code HGX·November 5, 2012

PUMP IN STYLE ADVANCED BREAST PUMP CANADA GO TOTE

FDA Adverse Event

Malfunction ·MEDELA, INC.·Product code HGX·August 27, 2012

PURELY YOURS

FDA Adverse Event

Malfunction ·AMEDA, INC.·Product code HGX·October 24, 2014

FREESTYLE BREAST PUMP

FDA Adverse Event

Injury ·MEDELA AG·Product code HGX·July 18, 2014

PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

FDA Adverse Event

Malfunction ·MEDELA, INC·Product code HGX·November 22, 2016