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Lower risk Medical device recall · FDA · Published July 26, 2017

Molnlyke 9x15" Medium Utility Positioner Recall: Metal Shavings Hazard

Molnlyke Health Care recalls 9x15" Medium Utility Positioner with Cover due to possible metal shavings. Affected units may not meet specifications. Contact for remedy details.

🇺🇸 FDA recall #Z-0417-2018Medical deviceMolnly:ke ›
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Contact the company

Recalling firmMolnlycke Health Care, Inc5550 Peachtree Pkwy Ste 500 · Norcross, GA 30092-2555
✎ GovInfoNow plain-language explainer

What happened, in plain English

Molnlyke Health Care is recalling 9x15" Medium Utility Positioner with Cover products because they may contain metal shavings that could cause injury. This recall affects medical equipment used in healthcare settings. Read more at govinfonow.com/recall/73351-molnlyke-9x15-medium-utility-positioner-recall-metal-shavings-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/73351-molnlyke-9x15-medium-utility-positioner-recall-metal-shavings-hazard · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0417-2018

Cite this page

“Molnlyke 9x15" Medium Utility Positioner Recall: Metal Shavings Hazard.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73351-molnlyke-9x15-medium-utility-positioner-recall-metal-shavings-hazard. Based on FDA recall #Z-0417-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2018%22&limit=1).

Why it’s dangerous

Metal shavings in the product could cause cuts or injuries if they come into contact with skin or medical equipment. The shavings may not meet safety specifications, leading to potential harm during use.

Who’s affected

Healthcare facilities and medical professionals who use the 9x15" Medium Utility Positioner with Cover are most at risk. Patients using this equipment could potentially be affected if metal shavings cause injury.

How to tell if you have this one

Check for the 9x15" Medium Utility Positioner with Cover model. This product was sold under Recorder Code 1400239. The recall applies to all units manufactured by Molnlyke Health Care.

  • Brand
    Molnly:ke
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
Recall numberProduct, codes & lotsQuantity
Z-0416-20187x10" Small Utility Positioner with Cover; Recorder Code 1400227960 units total
Z-0417-20189x15" Medium Utility Positioner with Cover; Recorder Code 1400239204 units total
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your unit has the 9x15" Medium Utility Positioner with Cover model and Recorder Code 1400239.

Where it went and when

Where it was distributed

Distributed in 17 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

1. Firm started the recall: Jul 26, 201712. FDA classified it Class II: Jan 26, 201823. Published in FDA’s Enforcement Report: Feb 7, 201834. FDA terminated the recall: Apr 6, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0417-2018 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0417-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA