Food, drugs, devices › Ecolab Inc
Device recall: Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Int
Ecolab Inc (Saint Paul, MN) initiated this device recall on 14 Sep 2018; FDA lists 4 product records under event 81244, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 12 Feb 2021. Initiation: voluntary: firm initiated. Ecolab Inc has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ecolab Inc, Saint Paul, MN.
Reason for recall
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0231-2019 | 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: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical… | 344 cases (6,880 eaches) | Class II | Terminated | 31 Oct 2018 |
| Z-0232-2019 | 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: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical… | 88 cases (1,760 eaches) | Class II | Terminated | 31 Oct 2018 |
| Z-0233-2019 | 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 Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or… | 4,861 cases (24,305 eaches) | Class II | Terminated | 31 Oct 2018 |
| Z-0234-2019 | 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 Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or… | 9,364 cases (46,820 eaches) | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Ecolab Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Feb 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.