DrugJun 26, 2019
Akorn Myorisan recall — FDA D-1392-2019
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class IIIFDA: TerminatedAkorn Inc.
June 2019 recalls — page 4
These records include useful source details for the selected month.
DrugJun 26, 2019
Preferred Pharmaceuticals Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL) recall — FDA D-1410-2019
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
DrugJun 26, 2019
P & L Developments Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine recall — FDA D-1407-2019
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with…
Class IIFDA: TerminatedP & L Developments, LLC
DrugJun 26, 2019
P & L Developments Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief recall — FDA D-1409-2019
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with…
Class IIFDA: TerminatedP & L Developments, LLC
DrugJun 26, 2019
Zydus Pharmaceuticals USA Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle recall — FDA D-1446-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class IIFDA: TerminatedZydus Pharmaceuticals USA Inc.
DrugJun 26, 2019
Sun Pharmaceutical Industries Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl recall — FDA D-1388-2019
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
VehicleJun 26, 2019
Subaru of structure recall — NHTSA campaign 19V493000
Subaru of America, Inc. (Subaru) is recalling certain 2019 Legacy and Outback vehicles. Spot welds located on the duct below the cowl panel may have been improperly applied, impacting the…
structureSubaru of America, Inc.
Medical DeviceJun 19, 2019
GE Healthcare Precision 500D The Precision 500D R&F X-ray System is intended to be used as a recall — FDA Z-1754-2019
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
Philips Patient Information Center iX configured with a regional setting which uses a comma recall — FDA Z-1771-2019
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX…
Class IIIFDA: TerminatedPhilips North America, LLC
Medical DeviceJun 19, 2019
Medtronic Neuromodulation InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) recall — FDA Z-1774-2019
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Class IIFDA: OngoingMedtronic Neuromodulation
Medical DeviceJun 19, 2019
Philips IntelliBridge System configured with a regional setting which uses a comma for a recall — FDA Z-1772-2019
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX…
Class IIIFDA: TerminatedPhilips North America, LLC
Medical DeviceJun 19, 2019
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas recall — FDA Z-1769-2019
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled,…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceJun 19, 2019
GE Healthcare GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 recall — FDA Z-1781-2019
There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
Maquet Cardiovascular Us Sales Getinge 86-Series-Medical Washer-Disinfector Part Number recall — FDA Z-1778-2019
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJun 19, 2019
Luminex Molecular Diagnostics xTAG Gastrointestinal Pathogen Panel intended for the recall — FDA Z-1767-2019
Reports have been received of lower MS2 MFI values when using the panel.
Class IIFDA: OngoingLuminex Molecular Diagnostics
Medical DeviceJun 19, 2019
GE Healthcare Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to recall — FDA Z-1752-2019
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
Maquet Cardiovascular Us Sales Getinge 86-Series-Medical Washer-Disinfector Part Number recall — FDA Z-1777-2019
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJun 19, 2019
Skytron, Div. The KMW Group Skytron Integrity 270 Steam Sterilizer and Skytron Integrity recall — FDA Z-1779-2019
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
Class IIFDA: TerminatedSkytron, Div. The KMW Group, Inc.
Medical DeviceJun 19, 2019
GE Healthcare Silhouette VR This fully integrated system offers intuitive controls with recall — FDA Z-1755-2019
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) recall — FDA Z-1705-2019
Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and…
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJun 19, 2019
GE Healthcare Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose recall — FDA Z-1751-2019
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
GE Healthcare Prestilix 1600X Prestilix system is a fully integrated remote controlled recall — FDA Z-1753-2019
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 19, 2019
Cardiocommand recall — FDA Z-1773-2019
Possible corrosion of the battery contact(s).
Class IIIFDA: TerminatedCardiocommand Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE MILK CHOCOLATE MEIJI, 1.75 oz recall — FDA F-1449-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
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.