Xeridiem Mediem Medical Devices Inc

Xeridiem Mediem Medical Devices Inc: 105 FDA recall reports

Every medical device recall the FDA has published for Xeridiem Mediem Medical Devices Inc. The fault, and how the agency graded it.

105Reports
0Class I
0Ongoing
2016-03-02Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II105
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Prof

Z-0932-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
37

EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Prof

Z-0973-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
34

EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Prof

Z-0981-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
39

EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Prof

Z-0912-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
36

EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Prof

Z-1009-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The EndoVive 3s Low Prof

Z-0979-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
39

EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Prof

Z-0947-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Prof

Z-0926-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
235

EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Prof

Z-0964-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
126

EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Prof

Z-0959-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
31

EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Prof

Z-0980-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Prof

Z-1015-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
32

EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Prof

Z-0953-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Prof

Z-0916-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
39

EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Prof

Z-0920-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
243

EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Pro

Z-0945-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
36

EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Prof

Z-0958-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
37

EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Prof

Z-0987-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
38

EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Prof

Z-1001-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Prof

Z-0967-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
38

EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Prof

Z-0993-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
39

EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Prof

Z-0930-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
34

EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Prof

Z-0961-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
36

EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Prof

Z-0923-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
77

EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Prof

Z-0936-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
77

EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Prof

Z-0978-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Prof

Z-0950-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
77

EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Prof

Z-0969-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
38

EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The EndoVive 3s Low Prof

Z-0989-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
40

EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Prof

Z-0921-2016  ·  Class II  ·  reported 2016-03-02  ·  Terminated

Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Where it went
Nationwide distribution to MA only.
How much
326

Showing the 30 most recent of 105. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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