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Lower risk Medical device recall · FDA · Published August 8, 2017

LifeCell REVOLVE Advanced Adipose System Recall: Bacterial Endotoxins Risk

LifeCell recalls REVOLVE Advanced Adipose System due to potential bacterial endotoxins above safe levels. Affected units have specific lot numbers with expiration dates through 2019. Consumers should check their product details.

🇺🇸 FDA recall #Z-0823-2018Medical deviceLifeCell ›
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Recalling firmLifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC1 Millennium Way · Branchburg, NJ 08876-3876
✎ GovInfoNow plain-language explainer

What happened, in plain English

LifeCell is recalling its REVOLVE Advanced Adipose System for aesthetic body contouring procedures because it may contain bacterial endotoxins above safe limits. This could pose a health risk if the product is used in medical procedures. Read more at govinfonow.com/recall/73159-lifecell-revolve-advanced-adipose-system-recall-bacterial-endotoxins-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/73159-lifecell-revolve-advanced-adipose-system-recall-bacterial-endotoxins-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0823-2018

Cite this page

“LifeCell REVOLVE Advanced Adipose System Recall: Bacterial Endotoxins Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73159-lifecell-revolve-advanced-adipose-system-recall-bacterial-endotoxins-risk. Based on FDA recall #Z-0823-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0823-2018%22&limit=1).

Why it’s dangerous

The product may contain bacterial endotoxins levels above the acceptable limit. Endotoxins are substances that can cause infections or adverse reactions when introduced into the body during medical procedures.

Who’s affected

People who purchased or use the REVOLVE Advanced Adipose System for body contouring procedures. Patients undergoing fat harvesting or transfer treatments are most at risk.

How to tell if you have this one

Check the lot number on the product packaging. Affected units have specific lot numbers with expiration dates from May 2017 through February 2019 as listed in the recall notice.

  • Brand
    LifeCell
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number on the product packaging to determine if it is affected. Affected units have specific lot numbers with expiration dates from May 2017 through February 2019.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Aug 8, 201712. FDA classified it Class II: Mar 1, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Sep 7, 2018420172018
  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-0823-2018 (August 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0823-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 18, 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