CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

Instrument Arm Drape (Box of individually sealed / Rx recalled by Ecolab

Ecolab is recalling Instrument Arm Drape (Box of individually sealed / Rx Sterile / to used exclusively on, distributed nationwide in the US. The recall was initiated on 14 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 420015-03 Lots # D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277

Quantity recalled344 cases (6,880 eaches)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0231-2019
FDA event ID: 81244
Recalling firm: Ecolab, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

14 Sep 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+39 days
31 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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]

Where it was distributed

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

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

Item 420015-03 Lots # D173357, D173337A, D180047A, D180207, D180057, D180127A, and D180277

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 81244

Reported	Class	Recall	Company	Reason	Where
31 Oct 2018	CLASS II	Camera Arm Drape (Box of individually sealed / Rx Sterile recalled	Ecolab	Sterility	Nationwide
31 Oct 2018	CLASS II	Disposable Accessory Kit, 3-Arm recalled by Ecolab	Ecolab	Sterility	Nationwide
31 Oct 2018	CLASS II	Disposable Accessory Kit, 4-Arm recalled by Ecolab	Ecolab	Sterility	Nationwide

More recalls from Ecolab

All 28

Reported	Class	Recall	Company	Reason	Where
3 Mar 2021Device	CLASS II	Slush + Warmer Disc Drape recalled by Ecolab	Ecolab	Sterility	Nationwide
2 Sep 2020Drug	CLASS II	Hand Sanitizer (Alcohol 80% v/v) topical solution recalled by Ecolab	Ecolab	Other	Nationwide
26 Jun 2019Drug	CLASS III	Quik-care Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol) recalledQuik-care	Ecolab	Labeling Errors	Nationwide
3 Apr 2019Drug	CLASS II	Gel Hand Sanitizer (Ethyl Alcohol 70%) recalled by EcolabEcolab	Ecolab	Benzene	Nationwide
3 Apr 2019Drug	CLASS II	Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), Ecolab recalled	Ecolab	Benzene	Nationwide

Other Surgical Instruments recalls

All 3,816

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide