FoodMar 6, 2019
Ottogi Spicy Seafood flavor Udon Odongtong 5PK 1lb 5.16oz x recall — FDA F-1072-2019
Undeclared allergen; egg.
Class IFDA: TerminatedOttogi America Inc.
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 177
Records are ordered by the best available source date.
FoodMar 6, 2019
Ottogi Ppushu Ppushu BBQ Flavor 3.17oz x 40ea Item #21503007 recall — FDA F-1068-2019
Undeclared allergen; egg.
Class IFDA: TerminatedOttogi America Inc.
FoodMar 6, 2019
ProThera, Inc. dba SFI USA Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg recall — FDA F-1101-2019
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Class IIIFDA: TerminatedProThera, Inc. dba SFI USA
DrugMar 6, 2019
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle recall — FDA D-0517-2019
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
VehicleMar 6, 2019
Volkswagen Group of coil springs recall — NHTSA campaign 19V188000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2017-2019 Golf Sportwagen, 2019 Jetta, 2015-2019 Golf, and 2018-2019 Tiguan vehicles. The rear coil springs may…
coil springsVolkswagen Group of America, Inc.
VehicleFeb 28, 2019
Ram 1500 12v/24v/48v battery recall — NHTSA campaign 19V142000
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 vehicles equipped with a 48v auxiliary battery system located behind the rear seat (sales code: XBZ). Due to an incorrect assembly…
12v/24v/48v batteryChrysler (FCA US LLC)
Medical DeviceFeb 27, 2019
Philips PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and recall — FDA Z-0860-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Philips PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up recall — FDA Z-0858-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Ortho-Clinical Diagnostics VITROS Chemistry Products VALP Reagent Pack recall — FDA Z-0848-2019
Negative bias results when using VITROS VALP Reagent, GEN 25.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceFeb 27, 2019
Philips PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up recall — FDA Z-0857-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Intuitive Surgical daVinci Harmonic ACE Curved Shears recall — FDA Z-0841-2019
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceFeb 27, 2019
Philips PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up recall — FDA Z-0859-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat recall — FDA Z-0840-2019
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent…
Class IIFDA: TerminatedRandox Laboratories Ltd.
Medical DeviceFeb 27, 2019
Philips PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up recall — FDA Z-0861-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Philips PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 recall — FDA Z-0855-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Leica Microsystems PROVEO 8 Ophthalmic Microscope System optical instrument for improving recall — FDA Z-0838-2019
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper…
Class IIFDA: TerminatedLeica Microsystems, Inc.
Medical DeviceFeb 27, 2019
Philips PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 recall — FDA Z-0856-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceFeb 27, 2019
Boston Scientific Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of recall — FDA Z-0852-2019
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceFeb 27, 2019
Ortho Clinical Diagnostics Vitros Myoglobin Calibrators, Product Code 6801043 For use in the recall — FDA Z-0844-2019
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Class IIFDA: TerminatedOrtho Clinical Diagnostics Inc.
Medical DeviceFeb 27, 2019
Baxter Healthcare AMIA Automated Peritoneal Dialysis System Product Usage: It is intended recall — FDA Z-0849-2019
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceFeb 27, 2019
Shimadzu Medical Systems Usa Com TRINIAS for diagnostic imaging and interventional recall — FDA Z-0864-2019
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the…
Class IIFDA: TerminatedShimadzu Medical Systems Usa Com
Medical DeviceFeb 27, 2019
Baxter Healthcare Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended recall — FDA Z-0850-2019
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceFeb 27, 2019
Smiths Medical ASD Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator recall — FDA Z-0843-2019
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceFeb 27, 2019
Philips PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 recall — FDA Z-0854-2019
Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby…
Class IIFDA: OngoingPhilips North America, LLC
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.