FoodSep 4, 2019
Olive Bakery Chestnut bread packages contain two bread pastries filled with recall — FDA F-2118-2019
Label declares flour but does not declare wheat.
Class IIFDA: TerminatedOlive Bakery
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 72
Records are ordered by the best available source date.
DrugSep 4, 2019
Akorn Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For recall — FDA D-1840-2019
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known…
Class IIIFDA: TerminatedAkorn, Inc.
DrugSep 4, 2019
Akorn Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC recall — FDA D-1841-2019
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class IIIFDA: TerminatedAkorn, Inc.
DrugSep 4, 2019
Akorn Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For recall — FDA D-1839-2019
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class IIIFDA: TerminatedAkorn, Inc.
DrugSep 4, 2019
Vivitrol recall — FDA D-1846-2019
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product…
Class IIFDA: TerminatedAlkermes Inc.
DrugSep 4, 2019
Pfizer RELPAX (eletriptan HBr) tablets, 40 mg recall — FDA D-1845-2019
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class IIFDA: TerminatedPfizer Inc.
DrugSep 4, 2019
Simvastatin Tablets, USP 40 mg recall — FDA D-1842-2019
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class IIIFDA: TerminatedAurobindo Pharma USA Inc.
VehicleAug 29, 2019
Jeep Gladiator driveshaft recall — NHTSA campaign 19V636000
Chrysler (FCA US LLC) is recalling certain 2020 Jeep Gladiator vehicles. The rear driveshafts may have been incorrectly assembled without grease in the monoblock joint.
driveshaftChrysler (FCA US LLC)
VehicleAug 29, 2019
Chrysler caliper recall — NHTSA campaign 19V635000
Chrysler (FCA US LLC) is recalling certain 2019 Ram 2500, 3500 and 3500 Cab Chassis trucks. The brake calipers may have been manufactured with an incorrect assembly fluid, which can cause…
caliperChrysler (FCA US LLC)
VehicleAug 29, 2019
Jeep Cherokee rack recall — NHTSA campaign 19V637000
Chrysler (FCA US LLC) is recalling certain 2019-2020 Jeep Cherokee vehicles. The steering rack gear may break, possibly causing a loss of steering control.
rackChrysler (FCA US LLC)
Medical DeviceAug 28, 2019
DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF recall — FDA Z-2293-2019
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceAug 28, 2019
Cincinnati Sub-Zero Products LLC, a Gentherm MICRO-TEMP LT System, Model 749- Localized Heat recall — FDA Z-2291-2019
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Class IIIFDA: TerminatedCincinnati Sub-Zero Products LLC, a Gentherm Company
Medical DeviceAug 28, 2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System recall — FDA Z-2224-2019
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max MRSA XT recall — FDA Z-2334-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Siemens Healthcare Diagnostics IMMULITE 2000 Progesterone recall — FDA Z-2290-2019
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood recall — FDA Z-2302-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max Enteric Bacterial Panel EU recall — FDA Z-2330-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection recall — FDA Z-2304-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max ExK DNA 2 USA recall — FDA Z-2325-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood recall — FDA Z-2298-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max Enteric Parasite Panel EU recall — FDA Z-2329-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Becton Dickinson & Company BD Vacutainer LH (Lithium Heparin) 102 I.U recall — FDA Z-2310-2019
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceAug 28, 2019
Becton Dickinson & Co Kit BD Max GC RT PCR Assay recall — FDA Z-2335-2019
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 28, 2019
Radiometer ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 recall — FDA Z-2320-2019
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot…
Class IIFDA: TerminatedRadiometer America Inc.
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.