Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER
Medical device recall Z-2291-2018. Published in FDA’s Enforcement Report on Jul 4, 2018.
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 Jul 4, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 70 coaxial hoses how much, in FDA’s words
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?
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
70 coaxial hoses, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SDH201607220029 SDH201607220030 SDH201607220031 SDH201607220032 SDH201607220033 SDH201607220034 SDH201607220035 SDH201607220036 SDH201607220037 SDH201607220038 SDH201607220039 SDH201607220040 SDH201607220041 SDH201607220043…
Every code shown here, 2,000 characters
Serial Numbers: SDH201607220029 SDH201607220030 SDH201607220031 SDH201607220032 SDH201607220033 SDH201607220034 SDH201607220035 SDH201607220036 SDH201607220037 SDH201607220038 SDH201607220039 SDH201607220040 SDH201607220041 SDH201607220043 SDH201607220044 SDH201607220046 SDH201607220048 SDH201607220049 SDH201607220050 SDH201607220051 SDH201607220052 SDH201607220053 SDH201607220054 SDH201607220055 SDH201607220056 SDH201607220057 SDH201607220058 SDH201607220059 SDH201607220060 SDH201607220061 SDH201607220062 SDH201607220063 SDH201607220064 SDH201607220065 SDH201607220067 SDH201607220068 SDH201607220069 SDH201607220070 SDH201607220071 SDH201607220072 SDH201607220073 SDH201607220075 SDH201607220076 SDH201607220077 SDH201607220078 SDH201607220079 SDH201607220080 SDH201607220081 SDH201607220082 SDH201607220083 SDH201607220084 SDH201607220085 SDH201607220086 SDH201607220087 SDH201607220088 SDH201607220089 SDH201607220090 SDH201607220091 SDH201607220092 SDH201607220093 SDH201607220094 SDH201607220095 SDH201607220096 SDH201607220097 SDH201607220098 SDH201607220099 SDH201607220047 SDH201607220001 SDH201607220002 SDH201607220003 SDH201607220004 SDH201607220005 SDH201607220006 SDH201607220007 SDH201607220008 SDH201607220009 SDH201607220010 SDH201607220011 SDH201607220012 SDH201607220013 SDH201607220014 SDH201607220015 SDH201607220016 SDH201607220017 SDH201607220018 SDH201607220019 SDH201607220020 SDH201607220021 SDH201607220022 SDH201607220023 SDH201607220024 SDH201607220025 SDH201607220026 SDH201607220027 SDH201607220028 SDH201607220042 SDH201607220045 SDH201607220066 SDH201607220074 SDH201804100101 SDH201804100102 SDH201804100103 SDH201804100104 SDH201804100105 SDH201804100106 SDH201804100107 SDH201804100108 SDH201804100109 SDH201804100110 SDH201804100111 SDH201804100112 SDH201804100113 SDH201804100114 SDH201804100115 SDH201804100116 SDH201804100117 SDH201804100118 SDH201804100119 SDH201804100120 SDH201804100121 SDH201804100122 SDH201804100123 SDH201804100124 SDH201804100125…
FDA’s list runs to 2,079 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.
CA, GA, MO, OH & TX
The states and territories these words name
- California
- Georgia
- Missouri
- Ohio
- Texas
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Apr 17, 2018.
- FDA classified it on Jun 26, 2018.
- FDA’s Enforcement Report published it on Jul 4, 2018.
- FDA terminated it on Jun 15, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Exsurco Medical, of Wakeman, OH.
- 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 2,079 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.