March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical: 29
Severe: 169
High: 353
Moderate: 197
Low: 24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

601–700 of 772

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 End
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-0895-2016·2016-03-02
Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 21 Olympus GIF-XP160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2016·2016-03-02
Olympus PCF-140L Video Colonoscope Recalled for Internal Coil Detachment
Integrated Medical Systems Inc is recalling three Olympus PCF-140L video colonoscopes because the internal coil pipe assembly may detach under excessive pressure.
Product
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2016·2016-03-02
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: 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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. 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: 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 End
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-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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2016·2016-03-02
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: 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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 77 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: 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 End
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-0825-2016·2016-03-02
Siemens BCS XP Analyzer Recalled for False Clotting Results
Siemens Healthcare Diagnostics is recalling BCS XP Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low INR values for specific patient samples.
Product
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2016·2016-03-02
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: M00548390 (XMD P/N 70-0050-614) 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 End
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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2016·2016-03-02
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: M00548310 (XMD P/N 70-0050-A12) 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 End
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-0963-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 91 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: M00548570 (XMD P/N 70-0050-816) 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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
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-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 End
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 End
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-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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2016·2016-03-02
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: M00548490 (XMD P/N 70-0050-G14) 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1000-2016·2016-03-02
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: M00548630 (XMD P/N 70-0050-E16) 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 154 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: M00548550 (XMD P/N 70-0050-616) 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0804-2016·2016-03-02
Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues
Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.
Product
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0868-2016·2016-03-02
Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
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 End
Category
Medical Device
Distribution
Distributed nationwide
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2016·2016-03-02
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: M00548770 (XMD P/N 70-0050-C18) 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 End
Category
Medical Device
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 End
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-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 End
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-0900-2016·2016-03-02
Olympus GIF-140 Video Gastroscope Recalled for Detached Coil Pipe Assembly
Integrated Medical Systems Inc is recalling 12 Olympus GIF-140 video gastroscopes because the internal coil pipe assembly may detach under pressure, causing angulation failure.
Product
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2016·2016-03-02
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: M00548810 (XMD P/N 70-0050-G18) 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 End
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 End
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-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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc 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: M00549520 (XMD P/N 70-0050-824) 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 End
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 End
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-0938-2016·2016-03-02
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: M00549340 (XMD P/N 70-0050-422) 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2016·2016-03-02
Olympus Video Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc is recalling one Olympus video colonoscope because excessive pressure may cause the internal coil pipe to detach, affecting angulation.
Product
Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
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 End
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 (Devices)·Z-0986-2016·2016-03-02
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: M00549410 (XMD P/N 70-0050-B22) 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 End
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 End
Category
Medical Device
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2016·2016-03-02
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: M00548950 (XMD P/N 70-0050-E20) 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0956-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 115 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: M00548560 (XMD P/N 70-0050-716) 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 End
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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0633-2016·2016-03-02
Roundy's Recalls Butternut Squash Ravioli for Undeclared Cashews and Almonds
Roundy's is recalling Simply Roundy's Butternut Squash Ravioli because it may contain undeclared cashews and almonds. The product was distributed in Illinois and Wisconsin.
Product
Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g). Packaged in a paper tray inside a plastic bag and wrapped around with paper band. Made in Italy. UPC 11150-50750
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0802-2016·2016-03-02
Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets
Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0629-2016·2016-03-02
Mahina Mele Farm Recalls Izzie Macs! Macadamia Nuts Due to Salmonella Risk
Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because samples tested positive for Salmonella. Consumers should stop eating the product and return it to the store.
Product
Izzie Macs! Macadamia Nuts - Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076793575; UPC 16 oz.: 689076792776. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 9
Category
Food
Distribution
0 states
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
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-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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0626-2016·2016-03-02
Penta International Recalls STREGA Araldi allo Chocolate Nougat for Undeclared Gluten
Penta International, Inc. is recalling STREGA Araldi allo Chocolate Nougat in New Jersey due to undeclared gluten. The recall is voluntary and has been terminated.
Product
STREGA Araldi allo (Chocolate nougat)
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0890-2016·2016-03-02
Olympus GIF-H180 Video Gastroscope Recalled for Distal Coil Detachment
Integrated Medical Systems Inc is recalling 275 Olympus GIF-H180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
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 End
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 End
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-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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 77 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: 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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2016·2016-03-02
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: 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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0631-2016·2016-03-02
Mahina Mele Farm Recalls Raw Mac Nut Butter Due to Salmonella
Mahina Mele Farm is recalling Baby Bruddah's Mac Nut Buttah because samples of raw macadamia nuts tested positive for Salmonella.
Product
Baby Bruddah's Mac Nut Buttah; Certified Organic by International Certification Services Inc.. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 753182242019 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
Category
Food
Distribution
0 states
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-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-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 End
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 End
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 polymer
Category
Medical Device
Distribution
6 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 End
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-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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2016·2016-03-02
Hill-Rom Bariatric Power Recliner Recalled for Missing Foot Rest Shields
Hill-Rom is recalling 216 Bariatric Power Recliners (Model P9096) because they were shipped without foot rest ottoman linkage side shields, which could result in consumer injury.
Product
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally sm
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-0919-2016·2016-03-02
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: M00549310 (XMD P/N 70-0050-122) 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 End
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 End
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 End
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 End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2016·2016-03-02
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: 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 End
Category
Medical Device
Distribution
Distributed nationwide

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