DrugMay 8, 2019
Customceutical Compounding HCG recall — FDA D-1256-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 155
Records are ordered by the best available source date.
DrugMay 8, 2019
Torrent Pharma Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) recall — FDA D-1267-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
Torrent Pharma Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90) recall — FDA D-1264-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
American Health Packaging GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10) recall — FDA D-1276-2019
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class IIFDA: TerminatedAmerican Health Packaging
DrugMay 8, 2019
Customceutical Compounding BPlex recall — FDA D-1254-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Torrent Pharma Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90) recall — FDA D-1266-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
Medical DeviceMay 1, 2019
Stryker Instruments Div. of Stryker Performance Series Sagittal Blade, Catalog Number recall — FDA Z-1215-2019
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation
Medical DeviceMay 1, 2019
Smiths Medical ASD Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4" recall — FDA Z-1218-2019
Several lots of Jelco ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceMay 1, 2019
Fenwal Fresenius Kabi CATSmart device recall — FDA Z-1209-2019
Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result…
Class IIFDA: TerminatedFenwal Inc.
Medical DeviceMay 1, 2019
GETINGE US SALES Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg recall — FDA Z-1221-2019
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Class IIIFDA: TerminatedGETINGE US SALES LLC
Medical DeviceMay 1, 2019
Abbott St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product recall — FDA Z-1220-2019
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Class IIFDA: TerminatedAbbott
Medical DeviceMay 1, 2019
Exactech Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product recall — FDA Z-1208-2019
2.5 Truliant Fit Trays were mismarked as 3
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceMay 1, 2019
Brainlab AG RT Elements Software revisions of the RT Elements applications have a specific recall — FDA Z-1205-2019
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam…
Class IIFDA: TerminatedBrainlab AG
Medical DeviceMay 1, 2019
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the recall — FDA Z-1214-2019
The bone screw is shorter than the intended design specification.
Class IIFDA: TerminatedTriMed Inc.
Medical DeviceMay 1, 2019
Guangzhou Improve Medical Instruments Co Prevent G Safety Winged Blood Collection Set Glide recall — FDA Z-1217-2019
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Class IIFDA: OngoingGuangzhou Improve Medical Instruments Co., Ltd.
Medical DeviceMay 1, 2019
COVIDIEN Procedure kits include devices from the affected lots distributed OUS only: (1)BOX recall — FDA Z-1213-2019
Sterilization method used was not consistent with the labeling and the approved sterilization method
Class IIFDA: TerminatedCOVIDIEN LLC
Medical DeviceMay 1, 2019
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for recall — FDA Z-1206-2019
Devices may generate excessive heat during use.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceMay 1, 2019
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF recall — FDA Z-1116-2019
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceMay 1, 2019
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto recall — FDA Z-1212-2019
Sterilization method used was not consistent with the labeling and the approved sterilization method
Class IIFDA: TerminatedCOVIDIEN LLC
Medical DeviceMay 1, 2019
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy recall — FDA Z-1204-2019
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 1, 2019
Ortho-Clinical Diagnostics VITROS XT 7600 Integrated System, Product Code 6844461, UDI recall — FDA Z-1222-2019
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 1, 2019
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II recall — FDA Z-1211-2019
Sterilization method used was not consistent with the labeling and the approved sterilization method
Class IIFDA: TerminatedCOVIDIEN LLC
Medical DeviceMay 1, 2019
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF recall — FDA Z-1117-2019
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceMay 1, 2019
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory recall — FDA Z-1203-2019
Small black plastic particle was observed in the left ventricle during implant procedure.
Class IIFDA: TerminatedThoratec Corp.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.