Ring, Teething, Fluid-filled
Dental · 21 CFR 872.5550
Recent MDR events
14 adverse event reports on file
- SOPHIE THE GIRAFFEJan 8, 2020InjuryUnkMW5092146
- LIFEFACTORY SILICONE TEETHING RINGAug 21, 2019UnkMW5089242
- NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUEApr 8, 2019MalfunctionUnknownMW5085707
- NUBYJul 3, 2018Luv N' Care Ltd.MW5078239
- TEETHING PRODUCT FILLED WITH GEL-LIKE BEADS, ELEPHANT SHAPEMay 7, 2018UnkMW5077078
- TEETHER/TEETHING RINGOct 1, 2013InjuryNubyMW5032119
- THE FIRST YEARS FLOATING FRIENDSOct 23, 2006Malfunction*MW1040772
- FIRST YEARS TEETHERMay 10, 2006Malfunction*MW1039118
- FIRST YEARSApr 21, 2006InjuryFirst YearsMW4004163
- THE FIRST YEARApr 6, 2006Malfunction*MW1038439
Event type breakdown
Recalls
9 recall events for this product code
- Tomy International Inc.Open, ClassifiedDec 22, 2022
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.
Z-0766-2023 · View FDA record ↗ - IMTEC CorporationTerminatedSep 10, 2009
MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant.
Size printed on product packaging does not match size of enclosed product.
Z-1997-2009 · View FDA record ↗ - Luv N' Care LtdTerminatedAug 12, 2009
Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool.
Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.
Z-1878-2009 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
Disney Days Hunny Cool Ring Teether
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0455-06 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
Disney Baby Soft Cool Ring Teether
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0456-06 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
Disney Baby Soft Cool Ring Teether
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0457-06 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
The First Years Cool Animal Teether/Fish, Zebra and Dinosaur designs
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0458-06 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
The First Years Floating Friend Teether
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0459-06 · View FDA record ↗ - RC2 Brands Inc., The First YearsTerminatedFeb 9, 2006
Sesame Beginnings Chill & Chew Teether
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
Z-0460-06 · View FDA record ↗
Registered firms
43 firms currently registered for this product code
Solid Toys Ind. Ltd.
Boluo County, Huizhou,City Guangdong, CN
Treasure Baby Toys (dongguan) Limited
Dongguan City Guangdong, CN
Sassy Baby, Inc
Gonzales, LA, US
Hong Kong Lute Technology Co., Limited
HONG KONG, HK
Dr. Brown's Company
Saint Louis, MO, US
Thaimed Hightech Co.,ltd.
Kabinburi Prachin Buri, TH
Ningbo Raffini Import & Export Co., Ltd
Ningbo Zhejiang, CN
Elung Industrial Co.ltd.
T.S.T.,KOWLOON, HONG KONG, CN
Tomy International
Dyersville, IA, US
Shantou Chaonan Liangying Hegao Plastic Toy Factory
SHANTOU Guangdong, CN
Kin Sun Industrial Ltd.
Kowloon, HK
Tomy International Inc., C/o Rc2 (h.k.) Ltd.
Kowloon Bay, HK
Gavin Biotechnology Co.,ltd
Jinzhong Shanxi, CN
Quintessential Tots, Llc
Naperville, IL, US
Essentia Industries Ltd.
Dong Guan Guangdong, CN
Polybell (guangzhou) Limited
Guangzhou Guangdong, CN
Dongguan Qing Xi Essentia Industries Ltd
Dongguan Guangdong, CN
Tomy International, Inc.
Canton, MA, US
Zenith Baby Care Co Ltd
Krathumbaen Samut Sakhon, TH
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd.
JIANGMEN, GUANGDONG, CN
Allied Hill Enterprises, Ltd.
Hong Kong, HK
Huizhou Xinghuayuan Houseware Co., Ltd
Huizhou City Guangdong, CN
510(k) clearances
27 clearances for this product code
- Solid Toys Ind. , Ltd.May 24, 2013
K123855 · WATER-FILLED TEETHER
- Bebe Toys Manufactory , Ltd.Dec 2, 2011
K110615 · WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
- Kids IIJan 27, 2011
K092025 · FLUID FILLED TEETHER - GEL
- Mam International AGJul 27, 2010
K093266 · MAM COOLER
- Mam International AGJun 23, 2010
K092781 · MAM TWISTER
- Luv N' Care, Ltd.Mar 1, 2010
K092494 · GEL FILLED GUM SOOTHER
- Fu Hong Industries , Ltd.Jan 21, 2010
K093370 · FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
- Qualiman Industrial Co., Ltd.Dec 18, 2009
K092910 · FLUID-FILLED TEETHER