Ecolab Recalls Slush and Warmer Disc Drapes Due to Sterile Barrier Risk
Ecolab is recalling specific lots of ORS-320 Slush + Warmer Disc Drapes because manufacturing slits may breach the sterile barrier, posing an infection risk to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Ecolab Inc is recalling 132 cases (3,168 drapes) of Model ORS-320 Slush + Warmer Disc Drapes, lot D192619A. These single-use equipment covers are intended for use during various surgeries where warm irrigation, slush, and/or cold solution is required.
The recall was initiated after slits were identified in a low quantity of drapes from this single lot. A potential manufacturing error was identified, and an investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between the 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 the affected drapes are used during a procedure. The affected products were distributed worldwide, including nationwide distribution in the United States and in Japan.
The recalled product
- Product
- 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.
- Manufacturer
- Ecolab Inc
- Category
- Medical Device — Surgical Drapes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model ORS-320
- lot D192619A
- 132 cases (3168 drapes)
Distribution
Related recalls
Same manufacturer · Ecolab Inc
See all →- ModerateEcolab Recalls Hand Sanitizer Due to Discoloration and Foreign Substance
FDA (Drugs) · 2020-09-02
- ModerateEcolab Recalls QUIK-CARE Hand Sanitizer Due to Incorrect Alcohol Ingredient
FDA (Drugs) · 2019-06-26
- ModerateEcolab Recalls Advanced Gel Hand Sanitizer Due to Chemical Contamination
FDA (Drugs) · 2019-04-03
- ModerateEcolab Recalls Quick-Care Foam Hand Sanitizer Due to Chemical Contamination
FDA (Drugs) · 2019-04-03
- ModerateEcolab Moisturizing Gel Hand Sanitizer Recalled for Chemical Contamination
FDA (Drugs) · 2019-04-03
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19