Entellus Medical
Medical device recall Z-0180-2021. Published in FDA’s Enforcement Report on Oct 28, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 28, 2020. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 1600998 / Catalog number 1600998-001 Serial Numbers: 17K0059 19A0042 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020…
Every code shown here, 1,995 characters
Model 1600998 / Catalog number 1600998-001 Serial Numbers: 17K0059 19A0042 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16L0001 16L0002 16L0003 16L0004 16L0005 16L0006 16L0007 16L0008 16L0009 16L0010 16L0011 16L0012 16L0013 16L0014 16L0015 16L0016 16L0017 16L0018 16L0019 16L0020 16L0021 16L0022 16L0023 16L0024 16L0025 16L0026 16L0027 16L0028 16L0029 16L0030 17A0001 17A0002 17A0003 17A0004 17A0005 17A0006 17A0007 17A0008 17A0009 17A0010 17A0011 17A0012 17A0013 17A0014 17A0015 17A0016 17A0017 17A0018 17A0019 17A0020 17A0021 17A0022 17A0023 17A0024 17A0025 17A0026 17A0027 17A0028 17A0029 17A0030 17C0001 17C0002 17C0003 17C0004 17C0005 17C0006 17C0007 17C0008 17C0009 17C0010 17C0011 17C0012 17C0013 17C0014 17C0015 17C0016 17C0017 17C0018 17C0019 17C0020 17C0021 17C0022 17C0023 17C0024 17C0025 17C0026 17C0027 17C0028 17C0029 17C0030 17D0001 17D0002 17D0003 17D0004 17D0005 17D0006 17D0007 17D0008 17D0009 17D0010 17D0011 17D0012 17D0013 17D0014 17D0015 17D0016 17D0017 17D0018 17D0019 17D0020 17D0021 17D0022 17D0023 17D0024 17D0025 17D0026 17D0027 17D0028 17D0029 17D0030 17E0001 17E0002 17E0003 17E0004 17E0005 17E0006 17E0007 17E0008 17E0009 17E0010 17E0011 17E0012 17E0013 17E0014 17E0015 17E0016 17E0017 17E0018 17E0019 17E0020 17E0021 17E0022 17E0023 17E0024 17E0025 17E0026 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17G0001 17G0002 17G0003 17G0004 17G0005 17G0006 17G0007 17G0008 17G0009 17G0010 17G0011 17G0012 17G0013 17G0014 17G0015 17G0016 17G0017…
FDA’s list runs to 4,186 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution including in the states of CA, MI and MN.
The states and territories these words name
- California
- Michigan
- Minnesota
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 11, 2020.
- FDA classified it on Oct 21, 2020.
- FDA’s Enforcement Report published it on Oct 28, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bien-Air Surgery Sa, of Le Noirmont, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,186 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.