Medical DeviceApr 10, 2019
Advanced Bionics Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140 recall — FDA Z-1085-2019
The sound processors were loaded with the incorrect firmware.
Class IIFDA: TerminatedAdvanced Bionics, LLC
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 163
Records are ordered by the best available source date.
Medical DeviceApr 10, 2019
Zimmer Biomet Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile recall — FDA Z-1086-2019
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceApr 10, 2019
Beaver Visitec Micro Knife 5.0mm 30, Part Number 0001522 The Beaver Micro Knife 5.0mm 30 is recall — FDA Z-1088-2019
The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
Class IIIFDA: TerminatedBeaver Visitec
Medical DeviceApr 10, 2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341 recall — FDA Z-1076-2019
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Class IIFDA: TerminatedAbbott Laboratories, Inc.
Medical DeviceApr 10, 2019
Abbott Laboratories CELL-DYN Emerald analyzer, REF 09H39-01 recall — FDA Z-1074-2019
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Class IIFDA: TerminatedAbbott Laboratories
Medical DeviceApr 10, 2019
Advanced Bionics Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120 recall — FDA Z-1084-2019
The sound processors were loaded with the incorrect firmware.
Class IIFDA: TerminatedAdvanced Bionics, LLC
FoodApr 10, 2019
Century Snacks Snak Club Honey Bliss Nut Mix: Honey Butter Flavored Almonds recall — FDA F-1232-2019
Internal label review discovered that Honey Butter Seasoning contains MILK allergen but allergen was not declared on finished packaging but rather was listed as Natural Flavors.
Class IIFDA: TerminatedCentury Snacks LLC
FoodApr 10, 2019
Fungi Perfecti Host Defense MycoBotanicals Blood Sugar, dietary supplement recall — FDA F-1231-2019
Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.
Class IIFDA: TerminatedFungi Perfecti LLC
FoodApr 10, 2019
Newport Ingredients Maika'i Sweet Honey Nut Snack Mix, Honey Sesame Sticks recall — FDA F-1234-2019
Notified by manufacturer of nut mix of recall due to undeclared milk.
Class IIFDA: TerminatedNewport Ingredients
FoodApr 10, 2019
Willamette Valley Pie Company, LLC Frozen IQF Strawberries packed in a flexible polybag recall — FDA F-1229-2019
Frozen IQF strawberries are recalled due to potential contamination with Hepatitis A virus.
Class IIFDA: TerminatedWillamette Valley Pie Company, LLC.
FoodApr 10, 2019
Better Made Snack Foods Family Size $3.99 Original Potato recall — FDA F-1235-2019
Undeclared milk
Class IIFDA: TerminatedBetter Made Snack Foods Inc.
FoodApr 10, 2019
Willamette Valley Pie Company, LLC Frozen IQF Red Raspberries packed in a flexible polybag recall — FDA F-1228-2019
Frozen IQF red raspberries are recalled due to potential contamination with Hepatitis A virus.
Class IIFDA: TerminatedWillamette Valley Pie Company, LLC.
FoodApr 10, 2019
Procesadora Aguas Claras LTDA Premium Sustainable Atlantic Salmon recall — FDA F-1211-2019
Direct customer tested Premium Sustainable Atlantic Salmon (Farm Raised) from Chile and had a positive result for Listeria monocytogenes.
Class IFDA: TerminatedProcesadora Aguas Claras LTDA.
DrugApr 10, 2019
Pacific Compounding Pharmacy & Consultations Cefuroxime 10mg/mL INJ 0.5 mg, SDV recall — FDA D-1076-2019
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the…
Class IIFDA: TerminatedPacific Compounding Pharmacy & Consultations Inc.
DrugApr 10, 2019
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial recall — FDA D-1067-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial recall — FDA D-1068-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials recall — FDA D-1070-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial recall — FDA D-1072-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
KRS Global Biotechnology NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / recall — FDA D-1079-2019
Labeling: Label mix-up
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugApr 10, 2019
Akorn Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle recall — FDA D-1080-2019
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class IIIFDA: TerminatedAkorn, Inc.
DrugApr 10, 2019
Legacy Pharmaceutical Packaging Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles recall — FDA D-1075-2019
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Class IIFDA: TerminatedLegacy Pharmaceutical Packaging LLC
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials recall — FDA D-1071-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL recall — FDA D-1073-2019
Presence of Particulate Matter; glass particulates
Class IFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial recall — FDA D-1069-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer 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.