Saint Paul, MN, United States

Ecolab Inc recalls

8 recalls recorded since 2018, most recently on 11 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls8

Ongoing (FDA)0

Terminated or completed8

Class I (FDA)0

Recall started: 11 January 2021
Terminated: 9 January 2023
Reason: 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.
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.
Initiated: Voluntary: Firm initiated
Recall number: Z-1141-2021

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21

Recall started: 10 May 2019
Terminated: 17 September 2022
Reason: Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Distribution: U.S.A. Nationwide
Initiated: Voluntary: Firm initiated
Recall number: D-1393-2019

QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82

Recall started: 6 February 2019
Terminated: 11 August 2022
Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Distribution: Nationwide within the United States
Initiated: Voluntary: Firm initiated
Recall numbers: D-1064-2019, D-1062-2019, D-1061-2019, D-1063-2019, D-1060-2019

Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Waba

Recall started: 9 November 2018
Terminated: 6 November 2020
Reason: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Distribution: U.S.A. Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: D-0274-2019, D-0275-2019

Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59

Recall started: 14 September 2018
Terminated: 12 February 2021
Reason: 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.
Distribution: Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY In the countries of Argentina, Australia, Au
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0231-2019, Z-0232-2019, Z-0233-2019, Z-0234-2019

Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Micro
Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microt
Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product

Recall started: 22 November 2017
Terminated: 22 July 2020
Reason: The incorrect IFU was shipped with the product.
Distribution: US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2333-2018, Z-2332-2018

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection ag
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection a

Recall started: 13 October 2017
Terminated: 22 July 2020
Reason: Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Distribution: Distributed domestically to Michigan.
Initiated: Voluntary: Firm initiated
Recall number: Z-0523-2018

Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.