Z-1204-2018Class II

Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in)

Name: Z-1204-2018 Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in)
Creator: Johnson & Johnson Consumer, Inc.
Published: 2017-12-18
License: https://open.fda.gov/license/

Kenvue Brands LLC / initiated 2017-12-18 / Terminated / root cause: labeling and UDI

FDA source

Johnson & Johnson Consumer, Inc. began a recall of Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in) on 2017-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1204-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Posted: 2018-03-27
Terminated: 2020-04-14
Recalling firm: Kenvue Brands LLC
Product: Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in)
Product code: FQM Bandage, Elastic
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected] and they will be notified. 2. Please complete the enclosed Business Reply Form and return immediately by emailing to [email protected] 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
Distribution: Nationally
Product codes and lots: 111615100 381371161515 103813711615120000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1204-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1201-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1202-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1203-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1204-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1205-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1206-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)