HFSClass I

Shield, Nipple

General Hospital · 21 CFR 880.5630

MDR events18All time

Recalls1All time

Registered firms53Currently listed

510(k) clearances12All time

Recent MDR events

18 adverse event reports on file

"KOALA SILVER CUPS" (ON THE BOX), "THE ORIGINAL NURSING CUPS 100% SILVER" (ON AMMay 18, 2026
InjuryHustle SrlMW5188370
SOFTSHELLS - SORE NIPPLESJun 16, 2020
InjuryMedela Ag1419937-2020-00058
NIPPLE SHIELD - 24 MM (STANDARD)Nov 21, 2019
InjuryMedela Ag1419937-2019-00151
PHILIPS AVENT NIPPLE PROTECTOROct 14, 2019
InjuryPhilips Electronics Uk Limited8021997-2019-00004
NIPPLE SHIELD (UNKNOWN)Mar 27, 2019
InjuryMedela Llc1419937-2019-00051
NIPPLE SHIELDJul 26, 2018
InjuryMedela Ag1419937-2018-00167
SOFTSHELLS - INVERTED NIPPLESSep 8, 2017
InjuryMedela Ag1419937-2017-00258
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE/BREASTSHIELDSJul 14, 2014
InjuryMedela, Inc.1419937-2014-00553
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTEApr 9, 2014
InjuryMedela, Inc.1419937-2014-00345
FREESTYLE HANDS FREE/BREASTSHIELD CONNECTORSMar 31, 2014
InjuryMedela, Inc.1419937-2014-00319

Event type breakdown

Injury16

Unspecified2

Most-reported manufacturers

Medela, Inc.8 Medela Ag4 Asteame Medical Devices Inc.1 Evenflo Co, Inc.1 Hustle Srl1 Medela Llc1 Medela, Inc1 Philips Electronics Uk Limited1

Recalls

1 recall events for this product code

Medela Inc
TerminatedJun 10, 2011
Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breast
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Z-2553-2011 · View FDA record ↗

Registered firms

53 firms currently registered for this product code

510(k) clearances

12 clearances for this product code