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Lower risk Medical device recall · FDA · Published October 13, 2017

Ecolab Disposable Light Handle Cover Recall: Sealed Pouch Gaps Risk Contamination

Ecolab recalls disposable light handle covers (item B1-715-65) due to potential gaps in sealed pouches that could allow contamination. Affected units include specific lot numbers from 14224 to 17192. Consumers should check their product labels and contact Ecolab for details.

🇺🇸 FDA recall #Z-0523-2018Medical deviceEcolab ›
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Contact the company

Recalling firmEcolab, Inc.940 Lone Oak Rd · Saint Paul, MN 55121-2214
✎ GovInfoNow plain-language explainer

What happened, in plain English

Ecolab is recalling disposable light handle covers that may have gaps in their sealed pouches, which could lead to contamination. This is a small risk for surgical lighting use but requires checking your product's lot number to see if it's affected. Read more at govinfonow.com/recall/72850-ecolab-disposable-light-handle-cover-recall-sealed-pouch-gaps-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72850-ecolab-disposable-light-handle-cover-recall-sealed-pouch-gaps-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0523-2018

Cite this page

“Ecolab Disposable Light Handle Cover Recall: Sealed Pouch Gaps Risk Contamination.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/72850-ecolab-disposable-light-handle-cover-recall-sealed-pouch-gaps-risk. Based on FDA recall #Z-0523-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0523-2018%22&limit=1).

Why it’s dangerous

The sterile packaging might have gaps in the seal, which could allow contaminants to enter the pouch during use. This is a potential contamination risk but does not pose a direct injury hazard.

Who’s affected

Surgical teams using the disposable light handle covers for lighting adjustments in medical settings. Those with the specific lot numbers listed in the recall are most at risk.

How to tell if you have this one

Check the product label for item number B1-715-65 and lot numbers from 14224 to 17192. The product comes in sealed pouches packaged 10 per box.

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

What to do — step by step

  1. Check Product Label

    Look for item number B1-715-65 and lot numbers listed in the recall (14224 to 17192) on the packaging.

Where it went and when

Where it was distributed

Distributed in Michigan.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed domestically to Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

1. Firm started the recall: Oct 13, 201712. FDA classified it Class II: Feb 5, 201823. Published in FDA’s Enforcement Report: Feb 14, 201834. FDA terminated the recall: Jul 22, 2020420172020
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using these covers immediately?

No, the recall only addresses potential packaging gaps that could lead to contamination. There is no immediate need to stop use.

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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-0523-2018 (October 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0523-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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