FDA Medical Device Recalls (openFDA)
Johnson & Johnson Consumer, Inc.: COACH Self-Adhering Sports Wrap (size: 2in)
- Recall number
- Z-1201-2018
- Recalling firm
- Johnson & Johnson Consumer, Inc.
- Product
- COACH Self-Adhering Sports Wrap (size: 2in)
- Status
- Terminated
- Initiated
- 2017-12-18
- Posted
- 2018-03-27
- Terminated
- 2020-04-14
- Reason
- 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.
- Root cause
- Labeling design
- Action
- On December 18, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to retailers and warehouses with intentions to notify all affected individuals, including customers of the recall. The recall letter requests that the following actions be taken: 1. Immediately examine your inventory and quarantine the above-mentioned product subject to recall. In addition, if you may have further distributed this product to retailers, warehouses or distributors, please identify and send a list of these locations to Stericycle at BandAid8687@stericycle.com and they will be notified. 2. Please complete the enclosed Business Reply Form and return immediately by emailing to BandAid8687@stericycle.com or faxing to (1-888-965-5802). 3. If you have any questions regarding the form, please call Stericycle at (1-855-215-5023). Please return ALL inventory of the identified product above. No product other than that specified is to be returned. Questions or concerns can be directed to 1-855-215-5023
- Quantity
- not on file
- Distribution
- Nationally
- Lot, serial or model codes
- 100497502 381370079286 3813700497530024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQM
- Firm FEI
- 2214133
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28