Archive
846 recalls were announced in November 2018.
Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.
Which agencies issued them
Working Cow Homemade Inc. is recalling 786 tubs of No Sugar Added Salted Caramel with Pecans Ice Cream due to potential Listeria monocytogenes contamination.
Maribel's Sweets, Inc. is recalling MarieBelle brand Japanese Matcha and White Chocolate Bars because they contain undeclared milk.
Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.
Working Cow Homemade Inc. is recalling 3-gallon tubs of Coffee Ice Cream due to potential Listeria monocytogenes contamination. The product was distributed to US consignees only.
Working Cow Homemade Inc. is recalling 2,012 tubs of Rum Raisin Ice Cream due to potential Listeria monocytogenes contamination.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Working Cow Homemade Inc. is recalling 28 tubs of JY Pistachio Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 190 tubs of Choc Chocolate Chip F.Y. Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 179 tubs of 3-gallon Red Velvet Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 997 tubs of Almond Joy Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 991 tubs of Georgia Peach Frozen Yogurt Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 311 tubs of Lactose Free PB Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling No Sugar Added Fudge Ripple Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling No Sugar Added Caramel Apple Ice Cream due to potential Listeria monocytogenes contamination.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Working Cow Homemade Inc. is recalling 786 tubs of Lactose Free Vanilla Ice Cream due to potential Listeria monocytogenes contamination.
Ukrop's Homestyle Foods is recalling Honey Turkey & Cheddar on White House Rolls because they may have contacted equipment used to process country ham recalled for Listeria monocytogenes.
Working Cow Homemade Inc. is recalling JY Heathbar Crunch Ice Cream due to potential Listeria monocytogenes contamination.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them to fail burst specifications.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
GE Healthcare is recalling 18 Millennium MC units because a detector can detach and fall.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
Deli Star Ventures Inc. dba King's Food Products is voluntarily recalling Chef's Request and Buckhead marinades due to undeclared soy and wheat allergens.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
Maribel's Sweets, Inc. is recalling Cacao Market Rosemary Truffle Salt 60% Dark Chocolate Bars because they contain undeclared milk.
GE Healthcare is recalling 1,166 Millennium MG gamma camera systems because a detector can detach and fall.
Great Dane Trailers is recalling 2019 Freedom Combo Drop Deck Platform trailers because the rear impact guards may be too narrow, potentially failing to prevent vehicles from going under the trailer in a crash.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
Simply Fresh Foods is recalling Rojo's Autentico Black Bean 5 Layer Dip due to potential Salmonella or Listeria monocytogenes contamination in the corn.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
Working Cow Homemade Inc. is recalling 26 tubs of JY Rum Raisin Ice Cream due to potential Listeria monocytogenes contamination.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA suture material degraded, causing them to fail burst specifications.
Working Cow Homemade Inc. is recalling 15 tubs of JY Pumpkin with Graham Ice Cream due to potential Listeria monocytogenes contamination.
Stryker is recalling Spirit Select Beds with high rail siderails due to non-compliance with safety standards and a potential risk of entrapment.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing some units to fail burst specifications.
Working Cow Homemade Inc. is recalling Sponge Bob Cookie Dough Ice Cream due to potential Listeria monocytogenes contamination.
Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 4x8cm devices because the PGA suture material degraded, causing the devices to fail burst specifications.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material may degrade, causing them to fail burst specifications.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
The Wornick Company is recalling Chef Sensations Fire Roasted diced onion/pepper blend due to potential Salmonella and Listeria contamination.
Working Cow Homemade Inc. is recalling No Sugar Added Creamsicle Ice Cream due to potential Listeria monocytogenes contamination.
Working Cow Homemade Inc. is recalling 3-gallon tubs of HV Chocolate Ice Cream due to potential Listeria monocytogenes contamination.
Wegmans Food Markets is recalling Placek Coffee Cake products because they contain undeclared milk, a major food allergen.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Working Cow Homemade Inc. is recalling 323 tubs of HV Coffee Ice Cream due to potential Listeria monocytogenes contamination.
Wegmans Food Markets is recalling 19-ounce Pumpkin Loaf products due to undeclared milk. The recall affects Wegmans stores in six states.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 18x22cm devices because the suture material degraded, causing them to fail burst specifications.
American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
Working Cow Homemade Inc. is recalling 399 tubs of Pumpkin Cheesecake Ice Cream due to potential Listeria monocytogenes contamination.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
R82 A/S is recalling 687 Heron toilet and bath chairs because they contain aluminum gas spring heads. The recall is a replacement campaign for these specific units.
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
GE Healthcare is recalling Aisys anesthesia systems because they may fail to transition to backup ventilation if a patient stops breathing spontaneously.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.
Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate 20 mg tablets due to cross-contamination with other products.
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.
Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.
Stryker is recalling 20,030 Spirit Plus hospital beds with high rail siderails due to non-compliance with safety standards and a potential risk of patient entrapment.
GE Healthcare is recalling 276 Millennium MyoSIGHT Nuclear Cardiology Imaging Systems because a detector can detach and fall.
Virtual Imaging is recalling 253 RadPRO Mobile 40kW Digital X-Ray Systems because the tube head may separate and fall off the unit.
Working Cow Homemade Inc. is recalling 505 tubs of Whala Whala Monkey Ice Cream due to potential Listeria monocytogenes contamination.
BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.
Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.
Arrow International is recalling 3,640 units of the AGB+ Multi-Lumen CVC Kit because some labels incorrectly state the spring-wire guide size as .032 instead of .025.
Espiner Medical Ltd is recalling 230 units of the Eco-Sac Tissue Retrieval System because the label incorrectly states the volume is 1200 ml instead of 1000 ml.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.
Medtronic is recalling 138 units of INFUSE Bone Graft X Small Kits because they may contain two absorbable collagen sponges instead of one.
Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.
Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.
Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.
Stryker Sustainability Solutions is recalling two reprocessed diagnostic EP catheters because they were identified as item # D134903 but are actually item # D134909, which is not approved for reprocessing.
Taro Pharmaceuticals is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) oral solution because an unknown impurity exceeded specified limits during stability testing.
Johnson & Johnson Surgical Vision is recalling 17 expired Abbott TECNIS intraocular lenses distributed in seven US states.
bioMérieux is recalling NucliSENS easyMAG Lysis Buffer because some eluates become colored due to remaining hemoglobin.
Straumann Manufacturing is recalling 21 units of Neodent GM Mini Conical Abutments because the laser-engraved label does not match the item in the package.
Eli Lilly is recalling 9,380 vials of ERBITUX (cetuximab) because some may be missing primary container labels. The recall covers specific states and Puerto Rico.
Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.
RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection because stability testing showed high pH levels that failed specifications.
The Kroger Co is recalling Simple Truth Organic Red Quinoa because the product was not in compliance for pesticide exclusion.
Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.
Right Value Drug Stores, Inc. is recalling 6,580 capsules of Progesterone SR 100 mg due to misbranding. The affected product was distributed in California.
Collagen Matrix, Inc. is recalling 569 units of BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box.
Right Value Drug Stores, Inc. is recalling Tadalafil SR 12 mg capsules distributed in California due to labeling misbranding.
Right Value Drug Stores, Inc. is recalling specific lots of Progesterone SR 200 mg Capsules due to misbranding. The affected products were distributed in California.
Right Value Drug Stores, Inc. is recalling Tadalafil SR 7 mg capsules due to misbranding. The affected lots were distributed in California.
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