Ecolab Inc: Medical Device Recall in 2021 - (Recall #: Z-1141-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2021

Date Posted: March 3, 2021

Recall Number: Z-1141-2021

Event ID: 87173

Reason for 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.

Status: Terminated

Product Quantity: 132 cases (3168 drapes)

Code Information:

Model ORS-320, lot D192619A, 132 cases (3168 drapes)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated