Z-0416-2018Class II

7x10" Small Utility Positioner with Cover

Name: Z-0416-2018 7x10" Small Utility Positioner with Cover
Creator: Molnlycke Health Care, Inc
Published: 2017-07-26
License: https://open.fda.gov/license/

Molnlycke Health Care / initiated 2017-07-26 / Terminated

FDA source

Molnlycke Health Care, Inc began a recall of 7x10" Small Utility Positioner with Cover on 2017-07-26. FDA classified it as Class II and gives the reason as "Products may not meet specifications due to possible presence of metal shavings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0416-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-26
Posted: 2018-01-26
Terminated: 2021-04-06
Recalling firm: Molnlycke Health Care
Product: 7x10" Small Utility Positioner with Cover
Product code: OUW Infant Positioner, Rx, Use In Highly Monitored Setting
Reason for recall: Products may not meet specifications due to possible presence of metal shavings.
FDA root cause: Under Investigation by firm
Action: Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.
Quantity in commerce: 960 units total
Distribution: Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
Product codes and lots: Recorder Code 1400227

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26
Z-0417-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26

Product code OUW

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)