Lower risk Medical device recall · FDA · Published January 11, 2021

Ecolab ORS-320 Slush + Warmer Disc Drapes Recall: Slits Risk Infection During Surgery

Ecolab recalls ORS-320 Slush + Warmer Disc Drapes with slits that could breach sterile barriers, risking infection during surgery. Affected units: 132 cases (3168 drapes) from lot D192619A.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1141-2021Medical device Ecolab ›

Lower-risk recall

Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.

Take action

Contact the company

Recalling firmEcolab Inc1 Ecolab Pl · Saint Paul, MN 55102-2739

✎ GovInfoNow plain-language explainer

Ecolab is recalling ORS-320 Slush + Warmer Disc Drapes that have slits in a small number of units. These slits could break the sterile barrier between fluid and equipment, potentially causing infections during surgery if used. Read more at govinfonow.com/recall/63436-ecolab-ors-320-slush-warmer-disc-drapes-recall-slits-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63436-ecolab-ors-320-slush-warmer-disc-drapes-recall-slits-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1141-2021

Cite this page

“Ecolab ORS-320 Slush + Warmer Disc Drapes Recall: Slits Risk Infection During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63436-ecolab-ors-320-slush-warmer-disc-drapes-recall-slits-risk. Based on FDA recall #Z-1141-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1141-2021%22&limit=1).

The FDA announced on Jan. 11, 2021, that Ecolab Inc is recalling Model ORS-320 Slush + Warmer Disc Drapes due to potential slits in the sterile barrier. This defect poses a risk of infection to patients receiving warmed irrigation fluid or surgical slush during procedures.

How to tell if you have it

Brand: Ecolab
Product: Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes
Lot code: D192619A
Quantity: 132 cases (3168 drapes)
Distribution: US Nationwide in AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA; Japan

The hazard

Slits were identified in a low quantity of the drapes from a single lot, potentially breaching the sterile barrier between fluid in the basin and the slush/warming equipment. This breach could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.

Context

GovInfoNow's records show Ecolab Inc has had 9 other recalls since Feb. 12, 2016. Other recent recalls include the July 30, 2020, Ecolab Hand Sanitizer Recall for discoloration and foreign substances, and the May 10, 2019, Ecolab QUIK-CARE Hand Sanitizer Recall involving wrong alcohol ingredients. Similar recent recalls of surgical products include the Dec. 16, 2025, Vortex Surgical device recall for compromised sterile pouches, the Jan. 28, 2026, Medline surgical drapes recall for fabric delamination, and the June 24, 2026, Covidien sutures recall for packaging tears.

How to tell if you have this one

Check for the model number ORS-320 on the drape packaging. The affected lot is D192619A, sold in 132 cases (3168 drapes) for surgical use.

Brand
Ecolab
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Drape Packaging
Look for the model number ORS-320 and lot number D192619A on the drape packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

FDA distribution: “Worldwide distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA. In the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Jan 11, 2021Firm started the recall
Feb 22, 2021FDA classified it Class II
Mar 3, 2021Published in FDA’s Enforcement Report
Jan 9, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/63436-ecolab-ors-320-slush-warmer-disc-drapes-recall-slits-risk">Ecolab ORS-320 Slush + Warmer Disc Drapes Recall: Slits Risk Infection During Surgery (GovInfoNow)</a>

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-1141-2021 (January 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1141-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.