Use cautionMedical device recall · FDA · Published September 14, 2018
Ecolab Instrument Arm Drape Recall: Pouch Seal Wrinkles Risk Sterility Breach
Ecolab recalls 20-piece sterile instrument arm drapes with potential pouch seal wrinkles that could breach sterility. Affected lots may cause contamination during surgery. Return or discard immediately.
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.
Take action
Contact the company
📍Recalling firmEcolab Inc1 Ecolab Pl · Saint Paul, MN 55102-2739
✎ GovInfoNow plain-language explainer
Ecolab is recalling 20-piece sterile instrument arm drapes that may have wrinkles in the pouch seal. These wrinkles could create a channel allowing contamination, risking infection during surgery. Affected lots include D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277. Read more at govinfonow.com/recall/69862-ecolab-instrument-arm-drape-recall-pouch-seal-wrinkles-risk-sterility.
“Ecolab Instrument Arm Drape Recall: Pouch Seal Wrinkles Risk Sterility Breach.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69862-ecolab-instrument-arm-drape-recall-pouch-seal-wrinkles-risk-sterility. Based on FDA recall #Z-0231-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0231-2019%22&limit=1).
The FDA announced on September 14, 2018, that Ecolab Inc is recalling Instrument Arm Drape products due to potential sterility breaches. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Ecolab
Product: Instrument Arm Drape (Box of 20)
Item Number: 420015-03
Lot Codes: D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277
Quantity: 344 cases (6,880 eaches)
Distribution: Worldwide, including US states AK through WY and countries such as Argentina, Australia, Canada, China, Germany, UK
The hazard
The FDA said the pouches of certain lots may have wrinkles along the seal that could create a channel. This defect could result in a breach in the sterility of the product.
Context
GovInfoNow's records show Ecolab Inc has issued 9 other recalls since February 12, 2016. Other recent recalls include the Ecolab ORS-320 Slush + Warmer Disc Drapes Recall (January 11, 2021) and the Ecolab Hand Sanitizer Recall (July 30, 2020). Similar product recalls include the Medline Convenience Kits Recall (June 12, 2026), the Medline ARTERIAL LINE INSERTION KIT Recall (June 12, 2026), and the Medline Surgical Drapes Recall (January 7, 2026).
How to tell if you have this one
Check the lot numbers: D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277. The product is a box of 20 sterile drapes for Intuitive Surgical Da Vinci Si robotic systems.
Brand
Ecolab
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom
Recall number
Product, codes & lots
Quantity
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 instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]; Item 420015-03 Lots # D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277
344 cases (6,880 eaches)
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 instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]; Item 420279-03 Lots # D180437A and D180567
88 cases (1,760 eaches)
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 nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]; Item 420290-03 Lots # D173047, D173557, D173017, D180127, D172917, D180137, D172827, D172897, D180197A, D172757, D173037, D173557A, D180297, D172907, D180127A, D173207, D172847, D180397, D180037, D180287, D180267, D180197, D180277, D180417, D172787, D180047, D173057, D180407, D172797, D173567, D180477, and D180607.
4,861 cases (24,305 eaches)
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 nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]; Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177, D173477, D180087, D173187, D173137, D172987, D173217, D173067, D173497, D173447, D173427, D173287, D180167, D180027, D173577, D173077, D180097, D180157, D173627, D173607, D173467, D173567, D180197, D173257, D173637, D173457, D180267, D180257, D172997, D173547, D180317, D180237, D173227, D173537, D173507, D180107, D173617, D173267, D180247, D173197, D180057, D180187, D180347, D180337, D180377, D180037, D180307, D180437, D173017,and D180507.
9,364 cases (46,820 eaches)
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Identify if your drapes have lot numbers D173357, D173337A, D180047A, D180207, D180057, D180127A, or D180277.
Discard or Return Drapes
If you have affected lots, discard the drapes immediately or return them to the manufacturer for replacement.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0231-2019 (September 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0231-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.