Archive
831 recalls were announced in August 2019.
Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.
Which agencies issued them
Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Siemens Medical Solutions is recalling two Lantis 6.1 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.
Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.
Herbal Doctor Remedies is recalling Deafness Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.
Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Herbal Doctor Remedies is recalling Herpes-P 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Ra Medical Systems is recalling four DABRA Laser units because they failed to calibrate during setup. The devices were distributed in California and Pennsylvania.
Herbal Doctor Remedies is recalling Stone Purger Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Awake 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.
DRG Instruments GmbH is recalling 38 kits of Salivary Testosterone ELISA because the assay may report testosterone levels that are too low.
Herbal Doctor Remedies is recalling Appetrol Capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Migraine Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Smoke End Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Detensin 500 mg capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Herbal Doctor Remedies is recalling Bone Fixer because it was manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Thyro-Lo 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Herbal Doctor Remedies is recalling Lipidtrol Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Mental Tonic Capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Siemens Medical Solutions is recalling 15 Lantis Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Siemens Medical Solutions is recalling Lantis systems due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Herbal Doctor Remedies is recalling Dragon Pain Balm because it was manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Glauco-Catar Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Stomach Flu Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Philips is recalling 27 iCT SP computed tomography systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Geistlich Pharma is recalling Bio-Oss Pen units because visible green plastic debris was found on the outer barrel when unscrewing the cap.
Herbal Doctor Remedies is recalling Lung Saver Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
Herbal Doctor Remedies is recalling Sperm Booster because it was manufactured outside of required Good Manufacturing Practice controls.
Philips is recalling 92 Ingenuity CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Lube Lax Capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Herbal Doctor Remedies is recalling Edema Off Capsules because they were manufactured outside of current Good Manufacturing Practices (CGMP) controls.
Herbal Doctor Remedies is recalling Asthma Balm 60 gram because it was manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Pain Away 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.
Herbal Doctor Remedies is recalling Herpes-G Capsules because they were manufactured outside of current Good Manufacturing Practices (CGMP) controls.
Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Fungo Balm because it was manufactured outside of required Good Manufacturing Practices controls.
Philips is recalling 12 Ingenuity TF PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Asma Stopper Capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Psoriasis Balm because it was manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Lump Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Herpes-S 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices.
Mott's LLP is recalling Penafiel Mineral Spring Water bottles because of elevated levels of inorganic arsenic. The recall covers 62,349 cases distributed nationwide.
Herbal Doctor Remedies is recalling Lung Fixer Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Hair Back 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Fungo Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Hyde & Hyde Inc is recalling Organic Asian Sesame Ginger packets due to potential contamination by rodent activity. All product was returned to the firm and none was further distributed.
Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Herbal Doctor Remedies is recalling Herpes-V Balm because it was manufactured outside of required Good Manufacturing Practices controls.
American Health Packaging is recalling 14,360 bottles of Lovastatin 40 mg tablets because the drug substance was out of specification for impurity results.
Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
Philips is recalling EPIQ and Affiniti ultrasound systems with software version 4.0 because patient images may be moved to the wrong folder.
Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.
Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.
Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream 0.1% because patients reported the product felt gritty. The recall covers 15g and 45g tubes distributed nationwide.
Herbal Doctor Remedies is recalling Anemia Off because it was manufactured outside of required Good Manufacturing Practices. The product was distributed nationwide in the US and Brazil.
Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
Geistlich Pharma is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.
Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
AAA Pharmaceutical is recalling Smart Sense Regular Strength Aspirin Tablets due to an incorrect expiration date on the label.
Sunshine Bottling Co. is recalling specific lots of Sunchy Malta beverage because the product did not meet taste specifications.
Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.
Randox Laboratories is recalling Assayed Bovine Multi-Sera Level 1 Control Lot 205SL to re-assign the Mean of all Instruments target and range for Bile Acids.
Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.
Sage Products Inc is voluntarily recalling a lot of Independent Care System kits because the included Sodium Bicarbonate Mouthpaste tubes may be cosmetically damaged.
SunSetter is recalling vinyl covers for motorized awnings because they can cause unexpected opening and falls. One death and six injuries have been reported.
Tiffin is recalling 2019-2020 Allegro Open Road motorhomes because a hydraulic hose may rub against the tire, causing sudden deflation and crash risk.
Kia is recalling 2020 Telluride vehicles because seat belt assemblies may not securely hold child restraints in a crash, increasing injury risk.
E-One is recalling 2019 Cyclone II and Typhoon fire trucks because air bag cushions may detach and fail to inflate during a crash.
Ford is recalling 2015 Fusion and Lincoln MKZ vehicles because heat from seat belt pretensioners may cause anchor cables to fail, increasing injury risk in crashes.
VanLeigh is recalling 2015-2019 Beacon and Vilano fifth wheel trailers because short suspension shackles may fail, increasing crash risk.
Mercedes-Benz is recalling 2020 GLE and GLS vehicles because incorrectly installed air conditioner drain hoses may cause water to enter the cabin, increasing the risk of fire.
Mercedes-Benz is recalling 2018-2019 GLA 250 vehicles because the rear middle seatbelt anchor may be loose, increasing injury risk in a crash.
Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because taillights may dim or turn off if the turn switch is moved quickly, increasing crash risk.
BMW is recalling 2020 745e xDrive vehicles because a software error may disable the audible seat belt warning for the driver, increasing injury risk in a crash.
Taylor Farms Illinois is recalling approximately 342 pounds of breaded chicken products due to a processing defect that may have led to undercooking.
Mercedes-Benz is recalling 2018-2019 C300 and C43 AMG vehicles because the 12-volt battery bracket may be unsecured, risking terminal disconnection in a crash.
Mercedes-Benz is recalling one 2019 S 450 vehicle because improperly installed pillar covers may prevent side curtain air bags from deploying correctly during a crash.
Dennis Eagle is recalling one 2017 Diego vehicle because a switch failure may cause instrument controls to move sides and disable the electronic braking system.
Forest River is recalling 2020 Columbus Fifthwheel Trailers because the rear ladder blocks the egress window, preventing emergency exit.
Navistar is recalling 2019-2020 IC RE and IC CE commercial buses because the roof hatch external handle may break, potentially preventing emergency egress.
Navistar is recalling 2,677 IC school buses because the roof hatch external handle may break, preventing emergency egress.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Drospirenone and Ethinyl Estradiol Tablets because they failed dissolution specifications during stability testing.
Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.
LNK International is recalling specific lots of Equate Nighttime Sleep Aid because of microbial contamination in the non-sterile product.
Terumo is recalling Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.
Growers Express is recalling Green Giant Fresh Cauliflower Crumbles due to a positive Listeria monocytogenes test result from a retail sample.
Looking for a different month? Back to 2019.