Z-0416-2015Class II

MediChoice Dual-Release Folding Walker with 5" wheel

Name: Z-0416-2015 MediChoice Dual-Release Folding Walker with 5" wheel
Creator: Owens & Minor Distribution, Inc.
Published: 2014-06-25
License: https://open.fda.gov/license/

Owens & Minor Distribution, Inc. / initiated 2014-06-25 / Terminated / root cause: manufacturing process

FDA source

Owens & Minor Distribution, Inc. began a recall of MediChoice Dual-Release Folding Walker with 5" wheel on 2014-06-25. FDA classified it as Class II and gives the reason as "Product wheels may be too loose, too tight, or fall off". 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-0416-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-11-20
Terminated: 2017-01-06
Recalling firm: Owens & Minor Distribution, Inc.
Product: MediChoice Dual-Release Folding Walker with 5" wheel
Product code: ITJ Walker, Mechanical
Reason for recall: Product wheels may be too loose, too tight, or fall off.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Customers were notified via letter and email by June 27, 2014. to take the following actions: 1. Designate a quarantine location in the DC for the recalled lots and serial numbers. 2. Label this area very clearly as "RECALLED PRODUCT IN QUARANTINE". 3. Clearly segregate the area to prevent the product from being moved or handled and to further designate that the product is in quarantine. 4. Record each case lot# or walker serial number if the product is out of the case on the recall inventory report. 5. Label each unit in the quarantine area with a label that clearly states RECALLED PRODUCT IN QUARANTINE. 6. Conduct a daily inventory verification check using to ensure the inventory still remains in quarantine. In addition, please forward a copy of this letter to hospital personnel in a position to notify patients who may have received and been discharged with a walker from the lots and serial numbers identified above. Hospital Customers: Contact your local DC Customer Service Representative who will assist in returning and replacing the recalled walker. Patients Who May Have Received a Recalled Walker from a Hospital: Contact Owens & Minor Mainstreet Customer Service at 1-800-818-6664 who will assist you in returning and replacing a walker.
Quantity in commerce: 1214 cases; 4 units/case
Distribution: US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.
Product codes and lots: Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20

Product code ITJ

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)