March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical: 29
Severe: 195
High: 329
Moderate: 195
Low: 24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.

Which agencies issued them

601–700 of 772

HighFDA (Devices)·Z-0943-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 80 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 205 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 32 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing solution or gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2016·2016-03-02
Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation
The Anspach Effort, Inc. is recalling 302 Synthes Small Electric Drive units because they may malfunction or start unintentionally.
Product
Synthes Small Electric Drive (SED)
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0922-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 33 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2016·2016-03-02
Olympus Pediatric Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems is recalling 190 Olympus PCF-H180AL pediatric colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Product
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0957-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 76 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0991-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 40 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak out.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0854-2016·2016-03-02
Philips IntelliVue Module Measurement X2 Recall for ST Alarm Failure
Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.
Product
Philips IntelliVue Module Measurement X2 Model: M3002A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 162 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0958-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 235 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 243 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1005-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1007-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2016·2016-03-02
Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation
Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.
Product
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 331 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1008-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2016·2016-03-02
Olympus CF-H180AL Video Colonoscope Recalled for Detached Coil Pipe Assembly
Integrated Medical Systems Inc. is recalling 232 Olympus CF-H180AL video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Product
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2016·2016-03-02
Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure
Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.
Product
Philips IntelliVue Measurement Module X1 Model: M3001A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem Mediem Medical Devices is recalling 77 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 91 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2016·2016-03-02
Olympus Video Duodenoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 16 Olympus TJF-160F video duodenoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Product
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2016·2016-03-02
Olympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD P/N 70-0050-B20) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2016·2016-03-02
Siemens Mammomat Inspiration Recall for Potential System Fatal Error
Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.
Product
Mammomat Inspiration with Tomosynthesis functionality
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0959-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 323 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0951-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0852-2016·2016-03-02
Stryker Spine Recalls AccuLIF Tubing Sets Due to Interference
Stryker Spine is recalling 413 AccuLIF PL and TL Tubing Sets because two potential interference conditions were identified with how the tubing attaches to the inserter.
Product
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leaks.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V123000·2016-03-02
Pierce Fire and Emergency Vehicles Recalled for Drive Shaft Fastener Defect
Pierce is recalling 2016 fire and emergency vehicles because a drive shaft fastener cap may be improperly tightened, posing a road hazard and crash risk.
Product
PIERCE — PIERCE VELOCITY, IMPEL, DASH CF, ARROW XT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0984-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing feeding solution or gastric contents to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 32 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 191 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1006-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0898-2016·2016-03-02
Olympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
Integrated Medical Systems Inc is recalling 26 Olympus CF-Q160L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Product
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2016·2016-03-02
Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems is recalling five Olympus video colonoscopes because the internal coil pipe assembly may detach if excessive pressure is applied to the distal end.
Product
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0621-2016·2016-03-02
Mary's Gone Crackers Thins Recalled for Potential Gluten Contamination
Mary's Gone Crackers, Inc. is recalling specific lots of gluten-free Thins snack crackers because they may contain gluten levels above the FDA limit.
Product
Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted. Organic, gluten free, non gmo, vegan; NET WT. 4.5 oz (127 g); UPC: 10897580000707; Mary's Gone Crackers, Inc. 199 Kentucky St., Gridley, CA 95948
Category
Food
Distribution
5 states
HighCPSC·16112·2016-03-02
Illume Recalls Valentine's Day Ceramic Mugs Due to Fire Hazard
Illume is recalling about 12,300 'Love Today' ceramic mugs sold at Target because the metallic print can spark in the microwave, posing a fire hazard.
Product
Love Today ceramic coffee mugs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 35 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD P/N 70-0050-D24) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2016·2016-03-02
Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc. is recalling 54 Olympus GIF-Q160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1004-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0964-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0929-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem Mediem Medical Devices is recalling 78 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak out.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing solution or gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0909-2016·2016-03-02
Olympus CF-Q140L Video Colonoscope Recalled for Internal Coil Detachment
Integrated Medical Systems Inc is recalling two Olympus CF-Q140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach.
Product
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0625-2016·2016-03-02
Great Pacific Bagel & Cream Cheese Recalled for Undeclared Wheat
Vern's & Son Food Service Distributing is recalling Great Pacific Bagel & Cream Cheese due to undeclared wheat. The product was distributed in Oregon and Washington.
Product
Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0961-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0908-2016·2016-03-02
Olympus Pediatric Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc. is recalling one Olympus PCF-H190L video pediatric colonoscope because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 260 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2016·2016-03-02
Teleflex Auto Endo5 Hem-o-lok Clip Applier Recall for Missing Boss
Teleflex Medical is recalling Auto Endo5 Hem-o-lok clip appliers because the clip may be missing a boss, which is needed to hold the clip in the applier jaws.
Product
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0997-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0903-2016·2016-03-02
Olympus CF-140L Video Colonoscope Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling nine Olympus CF-140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2016·2016-03-02
Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 82 Olympus CF-Q180AL video colonoscopes because excessive pressure may cause the internal coil pipe to detach, preventing proper angulation.
Product
Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2016·2016-03-02
Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc. is recalling 43 Olympus CF-Q160AL video colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Product
Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0999-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (XMD P/N 70-0050-E14) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V124000·2016-03-02
Husqvarna TR650 Motorcycles Recalled for Unexpected Stalling Risk
KTM is recalling 2013-2014 Husqvarna TR650 motorcycles because they may unexpectedly stall, increasing the risk of a crash.
Product
HUSQVARNA — HUSQVARNA TR650
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2016·2016-03-02
Xeridiem EndoVive Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2016·2016-03-02
Centurion Convenience Kits Recalled Due to Cracking IV Connector Threads
Centurion Medical Products is recalling convenience kits containing In-Vision-Plus Needleless IV Connectors because molding defects may cause threads to crack and tubing to detach.
Product
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0980-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2016·2016-03-02
Philips IntelliVue Info Center iX Software Recall for ECG Waveform Misrepresentation
Philips is recalling IntelliVue Info Center iX software because reconstructed ECG leads may misrepresent waveforms in specific leads.
Product
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 165 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2016·2016-03-02
Olympus Video Gastroscope Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc. is recalling nine Olympus GIF-Q140 video gastroscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 186 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1001-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2016·2016-03-02
Olympus GIF-160 Video Gastroscope Recalled for Internal Coil Detachment
Integrated Medical Systems Inc is recalling 111 Olympus GIF-160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0915-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 199 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2016·2016-03-02
Olympus GIF-Q180 Video Gastroscope Recall for Detached Coil Assembly
Integrated Medical Systems Inc. is recalling 185 Olympus GIF-Q180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Product
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) 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…
Category
Medical Device
Distribution
Distributed nationwide

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