Ecolab recalls

Ecolab appears in 28 official U.S. recall notices indexed by RecallRadar, most recently on 2021-03-03.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Slush + Warmer Disc Drape
  FDA Device · Class II · 2021-03-03 · Ecolab
  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…
• 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
  FDA Drug · Class II · 2020-09-02 · Ecolab
  Reason: Discoloration and Presence of Foreign Substance
• 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 U…
  FDA Drug · Class III · 2019-06-26 · Ecolab
  Reason: Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
• 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) bott…
  FDA Drug · Class II · 2019-04-03 · Ecolab
  Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
• Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102
  FDA Drug · Class II · 2019-04-03 · Ecolab
  Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
• 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 4759…
  FDA Drug · Class II · 2019-04-03 · Ecolab
  Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
• Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102
  FDA Drug · Class II · 2019-04-03 · Ecolab
  Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
• Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102
  FDA Drug · Class II · 2019-04-03 · Ecolab
  Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
• Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55…
  FDA Drug · Class II · 2018-11-28 · Ecolab
  Reason: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
• 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, N…
  FDA Drug · Class II · 2018-11-28 · Ecolab
  Reason: Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
• Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su…
  FDA Device · Class II · 2018-10-31 · Ecolab
  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…
• Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinc…
  FDA Device · Class II · 2018-10-31 · Ecolab
  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…
• Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su…
  FDA Device · Class II · 2018-10-31 · Ecolab
  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…
• Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da…
  FDA Device · Class II · 2018-10-31 · Ecolab
  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…
• 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/sh…
  FDA Device · Class III · 2018-07-11 · Ecolab
  Reason: The incorrect IFU was shipped with the product.
• 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/s…
  FDA Device · Class III · 2018-07-11 · Ecolab
  Reason: The incorrect IFU was shipped with the product.
• Disposable Light Handle Cover, Item Number B1-715-65
  FDA Device · Class II · 2018-02-14 · Ecolab
  Reason: Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
• Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Numb…
  FDA Drug · Class III · 2017-02-08 · Ecolab
  Reason: Subpotent Drug
• Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only
  FDA Device · Class III · 2016-12-21 · Ecolab
  Reason: 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…
• Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, It…
  FDA Device · Class II · 2016-09-14 · Ecolab
  Reason: 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.
• Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250…
  FDA Drug · Class III · 2016-03-16 · Ecolab
  Reason: Subpotent drug
• Microtek Medical, Inc
  FDA Device · Class II · 2015-09-30 · Ecolab
  Reason: 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…
• MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Micr…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 2…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Rep…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 2…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Med…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical…
  FDA Device · Class II · 2014-02-19 · Ecolab
  Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.