Bassinet, Hospital
General Hospital · 21 CFR 880.5145
Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.
Recent MDR events
104 adverse event reports on file
- NARA, DOMESTICJul 28, 2026MalfunctionStryker Medical-kalamazoo0001831750-2026-99417
- NARA, INTERNATIONALJul 27, 2026MalfunctionStryker Medical-kalamazoo0001831750-2026-99387
- NARA, DOMESTICJan 27, 2026MalfunctionStryker Medical-kalamazoo0001831750-2026-99130
- NARA, DOMESTICOct 27, 2025MalfunctionStryker Medical-kalamazoo0001831750-2025-99343
- NARA, DOMESTICOct 27, 2025MalfunctionStryker Medical-kalamazoo0001831750-2025-99340
- NARA, DOMESTICJan 28, 2025MalfunctionStryker Medical-kalamazoo0001831750-2025-00150
- NARA, DOMESTICOct 29, 2024MalfunctionStryker Medical-kalamazoo0001831750-2024-01262
- NARA, DOMESTICJul 29, 2024MalfunctionStryker Medical-kalamazoo0001831750-2024-01025
- NARA, DOMESTICApr 23, 2024MalfunctionStryker Medical-kalamazoo0001831750-2024-00635
- NARA, DOMESTICOct 23, 2023MalfunctionStryker Medical-kalamazoo0001831750-2023-01079
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Inflation Problem”
No history to chart.
Recalls
2 recall events for this product code
- Stryker Medical Division of Stryker CorporationTerminatedFeb 7, 2019
Naera Hospital Bassinet, Model No. 4402
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.
Z-0813-2019 · View FDA record ↗ - Nemschoff Chairs, Inc.TerminatedFeb 1, 2012
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04
To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
Z-0832-2012 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Flying Tooling Engineering Limited
Dongguan Guangdong, CN
Blickman Industries Llc
Lawrenceburg, TN, US
Couplet Care, Inc.
Greenville, NC, US
Pt. Mega Andalan Kalasan
JOGYAKARTA Yogyakarta, ID
Hebei Jiede Medical Equipment Co., Ltd.
Hengshui Hebei, CN
Midwest Products And Engineering
Milwaukee, WI, US
Stryker Medical
Portage, MI, US
Industrias Metalicas Los Pinos Sa
ITAGUI Antioquia, CO
Novum Medical Products
AMHERST, NY, US
Jiangsu Yongfa Medical Equipment Technology Co., Ltd
Zhangjiagang City Jiangsu, CN
Neolight, Llc
Scottsdale, AZ, US
Atom Medical Corporation
Sakura-ku, Saitama-shi, JP
Pedigo Products, Inc.
VANCOUVER, WA, US
Hard Mfg. Co., Inc.
BUFFALO, NY, US
Hill-rom, Inc.
Batesville, IN, US
Hill-rom De Mexico S De Rl De Cv
APODACA Nuevo Leon, MX
Industrial Woodworking Corp.
Zeeland, MI, US
Halo Dream, Inc.
New York, NY, US
Steris Corporation
MONTGOMERY, AL, US
Advanced Instrumentations, Inc.
Miami, FL, US
Amico Patient Care Corporation
Richmond Hill Ontario, CA
Dragon Medical Co.,ltd
Suzhou City Jiangsu, CN
Imperial Surgical Ltd.
Lachine Quebec, CA
Logistiplast Ltd
MOSHAV RINATYA Central, IL
Pedicraft, Inc.
JACKSONVILLE, FL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.