CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report

" Small Utility Positioner with Cover recalled by Molnlycke Health Care

Molnlycke Health Care is recalling " Small Utility Positioner with Cover, distributed in 17 states. The recall was initiated on 26 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRecorder Code 1400227

Quantity recalled960 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0416-2018
FDA event ID: 78058
Recalling firm: Molnlycke Health Care, Norcross, GA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2017
FDA classified: 26 Jan 2018
Reported: 7 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

26 Jul 2017	Recall initiated by company
26 Jan 2018	Classified by FDA	+184 days
7 Feb 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products may not meet specifications due to possible presence of metal shavings.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

7x10" Small Utility Positioner with Cover

Where it was distributed

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

Arkansas Connecticut Florida Georgia Iowa Illinois Louisiana Massachusetts Michigan Minnesota North Carolina Nebraska New York Ohio Texas Virginia Wisconsin

Questions about this recall

Is " Small Utility Positioner with Cover recalled?

Yes. Molnlycke Health Care recalled " Small Utility Positioner with Cover on 26 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0416-2018.

Why was it recalled?

Products may not meet specifications due to possible presence of metal shavings.

Which lots are affected?

Recorder Code 1400227

Where was it sold?

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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All 4

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