Johnson & Johnson Consumer, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Johnson & Johnson Consumer, Inc. makes
Johnson & Johnson Consumer, Inc. manufactures light therapy masks designed for skincare applications, including the Neutrogena Light Therapy Aging Mask+ and Neutrogena Light Therapy Acne Mask+. These devices emit specific wavelengths of light to target aging signs and acne on the skin.
The company’s products fall under FDA Class II devices and are authorised through the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Neutrogena Light Therapy Aging Mask+ Ref K180856
Regimes: 510(k) Registry: 510(k)Neutrogena Light Therapy Acne Mask+ Ref K180847
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Johnson & Johnson Consumer, Inc., initiated on 2017-12-18. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 6
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 18 Dec 2017 Z-1201-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
- 18 Dec 2017 Z-1202-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
- 18 Dec 2017 Z-1203-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
- 18 Dec 2017 Z-1204-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
- 18 Dec 2017 Z-1205-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
- 18 Dec 2017 Z-1206-2018 Class II Terminated Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.
Frequently asked questions
How many devices does Johnson & Johnson Consumer, Inc. have in the registry?
The registry currently lists 2 devices for Johnson & Johnson Consumer, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Johnson & Johnson Consumer, Inc.'s devices?
Among its 2 most recently registered devices, Johnson & Johnson Consumer, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Johnson & Johnson Consumer, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Johnson & Johnson Consumer, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Johnson & Johnson Consumer, Inc.?
FDA recall records list 6 recalls initiated by Johnson & Johnson Consumer, Inc., the most recent initiated on 18 Dec 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Johnson & Johnson Consumer, Inc. in the registry?
The most recently registered devices listed for Johnson & Johnson Consumer, Inc. include Neutrogena Light Therapy Aging Mask+ and Neutrogena Light Therapy Acne Mask+.