FDA Device recall Z-2291-2018
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 by Exsurco Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2291-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-17 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exsurco Medical |
| Distribution | CA, GA, MO, OH, TX |
Product
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
Reason
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.
Identifiers
| code_info | Serial Numbers: SDH201607220029 SDH201607220030 SDH201607220031 SDH201607220032 SDH201607220033 SDH201607220034…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 SDH20160722009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.