Medical DeviceNov 21, 2018
Luminex VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits recall — FDA Z-0445-2019
Potential to lead to a false negative results.
Class IIFDA: TerminatedLuminex Corporation
November 2018 recalls — page 5
These records include useful source details for the selected month.
Medical DeviceNov 21, 2018
Arthrex 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail recall — FDA Z-0442-2019
There is potential to break during use.
Class IIFDA: OngoingArthrex, Inc.
Medical DeviceNov 21, 2018
Zimmer Biomet Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The recall — FDA Z-0448-2019
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G recall — FDA Z-0435-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Siemens Healthcare Diagnostics Dimension Lipase Flex Reagent Cartridge, Model Number recall — FDA Z-0465-2019
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 21, 2018
Covidien Parietex Composite Parastomal Mesh recall — FDA Z-0461-2019
The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G recall — FDA Z-0418-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G recall — FDA Z-0432-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G recall — FDA Z-0423-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G recall — FDA Z-0429-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Zimmer Biomet Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The recall — FDA Z-0450-2019
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 21, 2018
GE Healthcare Touchscreen display kit recall — FDA Z-0413-2019
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL recall — FDA Z-0370-2019
A detector can detach and fall.
Class IFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G recall — FDA Z-0416-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Siemens Medical Solutions USA ARTIS Q.zen biplane with Material 10848355 - a Angiographic recall — FDA Z-0459-2019
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceNov 21, 2018
Zimmer Biomet Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The recall — FDA Z-0449-2019
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 21, 2018
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. recall — FDA Z-0468-2019
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceNov 21, 2018
GE Healthcare Aisys CS2 Anesthesia System recall — FDA Z-0412-2019
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G recall — FDA Z-0421-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Siemens Healthcare Diagnostics Dimension Vista Lipase Flex Reagent Cartridge, Model Number recall — FDA Z-0466-2019
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 21, 2018
Zimmer Biomet Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus recall — FDA Z-0453-2019
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 21, 2018
Siemens Medical Solutions USA ARTIS Q biplane with Material 10848282- - a Angiographic x-ray recall — FDA Z-0458-2019
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceNov 21, 2018
Zimmer Biomet Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus recall — FDA Z-0452-2019
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 21, 2018
Stryker Medical Division of Stryker The Spirit Plus Bed, Model 5600 Spirit Plus /with high recall — FDA Z-0438-2019
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.