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Sign in to claim this brandEcolab, Inc.
US
Last updated May 31, 2026
What Ecolab, Inc. makes
Ecolab manufactures single-use medical device cleaning and disinfection wipes, point-of-use (POU) water filtration systems including spray outlets, shower wands, and filters, and fluid warming solutions such as slush warmer drapes, warming plates, and intra-operative temperature management devices. The company also produces airway management products like disposable airway tubes and scope pillow warmers for medical procedures.
These products are regulated under FDA classifications, primarily as Class I and Class II devices, with some authorised via the 510(k) pathway and others through the Unique Device Identification (UDI) system. The company’s devices are listed in the FDA’s regulatory databases, including the 510(k) premarket notification and UDI records. Ecolab, Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 1-866-781-8787
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 006154611
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ecolab Bleach Disinfectant Wipe | 931548 | FDA UDI | Class I | Active |
| Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | K182164 | FDA 510(k) | Class II | Active |
| Non-Sterile Ors Warning Drapes/Slush+warmer Disc-Drape/Slush+warmer Palte-Drape /fluid Warmer Drape, Skirted | K142080 | FDA 510(k) | Class I | Active |
| Ecolab POU Water Filter | K173164 | FDA 510(k) | Class II | Active |
| IntraTemp Solution Warmer | K150190 | FDA 510(k) | Class I | Active |
| Non-Sterile Ors-400n Scope Pillow Warmer Drape | K142173 | FDA 510(k) | Class I | Active |
| #400 Brook Airway & #900 Professional Brook Airway | K883593 | FDA 510(k) | Class I | Active |
| ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | K152522 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (17)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Ecolab, Inc. has 17 recall records initiated between July 2, 2013, and January 11, 2021, all of which are marked as terminated. The recalls involve sterile packaging issues, including potential gaps, channels, or holes in seals and pouches, incorrect expiration dates on labels, missing or improper endotoxin testing, and slits in certain drapes. Additional reasons include incorrect instructions for use (IFU) and manufacturing errors affecting product sterility.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 11, 2021 | Z-1141-2021 | — | terminated | 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. |
| Sep 14, 2018 | Z-0231-2019 | — | terminated | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. |
| Sep 14, 2018 | Z-0232-2019 | — | terminated | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. |
| Sep 14, 2018 | Z-0233-2019 | — | terminated | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. |
| Sep 14, 2018 | Z-0234-2019 | — | terminated | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. |
| Nov 22, 2017 | Z-2333-2018 | — | terminated | The incorrect IFU was shipped with the product. |
| Nov 22, 2017 | Z-2332-2018 | — | terminated | The incorrect IFU was shipped with the product. |
| Oct 13, 2017 | Z-0523-2018 | — | terminated | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| Nov 30, 2016 | Z-0753-2017 | — | terminated | The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels. |
| Jul 14, 2016 | Z-2744-2016 | — | terminated | Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch. |
| Aug 18, 2015 | Z-2793-2015 | — | terminated | The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure. |
| Jul 2, 2013 | Z-0948-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| Jul 2, 2013 | Z-0945-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| Jul 2, 2013 | Z-0947-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| Jul 2, 2013 | Z-0946-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| Jul 2, 2013 | Z-0944-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |
| Jul 2, 2013 | Z-0943-2014 | — | terminated | Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. |