CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report
Amalgatome SD, Coaxial Pneumatic Hose, Schrader recalled
Exsurco Medical is recalling Amalgatome SD, Coaxial Pneumatic Hose, Schrader, distributed in California, Georgia, Missouri, Ohio, Texas. The recall was initiated on 17 Apr 2018 and the FDA has classified it as Class II.
Check your package
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-2291-2018
- FDA event ID
- 80300
- Recalling firm
- Exsurco Medical, Wakeman, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2018
- FDA classified
- 26 Jun 2018
- Reported
- 4 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Apr 2018 | Recall initiated by company | |
| 26 Jun 2018 | Classified by FDA | +70 days |
| 4 Jul 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
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.
Product as listed by the FDA
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
Where it was distributed
CA, GA, MO, OH & TX
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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 SDH201804100126 SDH201804100127 SDH201804100128 SDH201804100129 SDH201804100130
Where was it sold?
CA, GA, MO, OH & TX
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.
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