Z-1649-2014Class II

Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case...

Name: Z-1649-2014 Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case...
Creator: Medline Industries Inc
Published: 2014-03-20
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2014-03-20 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is... on 2014-03-20. FDA classified it as Class II and gives the reason as "This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1649-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Posted: 2014-05-21
Terminated: 2017-11-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
Product code: FQM Bandage, Elastic
Reason for recall: This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.
Quantity in commerce: 2,860 bandages
Distribution: Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Product codes and lots: Product Number: DYNJ05116A . Lot Number: 13LA1009.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1649-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1649-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)