Medical DeviceFeb 28, 2018
Zimmer Biomet ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device recall — FDA Z-0638-2018
Robot arm being sent to the wrong position
Class IIFDA: TerminatedZimmer Biomet, Inc.
Recall records from February 2018
These records include useful source details for the selected month.
Medical DeviceFeb 28, 2018
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT recall — FDA Z-0645-2018
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
Class IIFDA: TerminatedMedtronic Perfusion Systems
FoodFeb 28, 2018
Holsum Baking Company Warehouse Frozen Unbaked Biscuits sold under the brand names of recall — FDA F-0823-2018
Firm was notified of a positive test result for Listeria monocytogenes.
Class IIFDA: TerminatedHolsum Baking Company Warehouse
FoodFeb 28, 2018
Flexfrost Protein Ice Cream Cinnamon Chai Flexfrost L.L.C recall — FDA F-0816-2018
The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
Class IIFDA: TerminatedFlexfrost
FoodFeb 28, 2018
National Frozen Foods Corporation--Seattle IQF blend product sold as Not Ready To Eat recall — FDA F-0825-2018
Frozen blend vegetable product containing green beans are recalled due to a potential contamination with Listeria monocytogenes.
Class IIFDA: TerminatedNational Frozen Foods Corporation--Seattle
FoodFeb 28, 2018
Aryzta Italian White Bread Dough Sticks recall — FDA F-0826-2018
Aryzta LLC is recalling multiple lots of bread dough following a supplier's recall of a yeast ingredient due to potential contamination with metal fragments.
Class IIFDA: TerminatedAryzta North America
FoodFeb 28, 2018
Gobugi Holdings Dried Anchovy, size recall — FDA F-0828-2018
Product is uneviscerated and has the potential to be contaminated with Clostridium botulinum.
Class IIFDA: TerminatedGobugi Holdings Inc.
FoodFeb 28, 2018
Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C recall — FDA F-0815-2018
The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
Class IIFDA: TerminatedFlexfrost
FoodFeb 28, 2018
National Frozen Foods Corporation--Seattle IQF Green beans, sold as Not Ready To Eat recall — FDA F-0824-2018
Frozen green beans are recalled due to a potential contamination with Listeria monocytogenes.
Class IIFDA: TerminatedNational Frozen Foods Corporation--Seattle
FoodFeb 28, 2018
Bob's Red Mill Natural Foods Organic Creamy Wheat Hot Cereal, Item number 6097C244, Pack recall — FDA F-0829-2018
Organic Creamy Wheat Hot Cereal is recalled due to undeclared wheat. The front label is correctly labeled as Organic Creamy Wheat Hot Cereal. However, the back label is mistakenly labeled…
Class IIIFDA: TerminatedBob's Red Mill Natural Foods, Inc.
FoodFeb 28, 2018
Flexfrost Protein Ice Cream Vanilla Flexfrost L.L.C recall — FDA F-0819-2018
The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
Class IIFDA: TerminatedFlexfrost
FoodFeb 28, 2018
Flexfrost Protein Ice Cream Coffee Flexfrost L.L.C recall — FDA F-0817-2018
The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
Class IIFDA: TerminatedFlexfrost
FoodFeb 28, 2018
Aryzta Italian White Bread Dough Sticks recall — FDA F-0827-2018
Aryzta LLC is recalling multiple lots of bread dough following a supplier's recall of a yeast ingredient due to potential contamination with metal fragments.
Class IIFDA: TerminatedAryzta North America
FoodFeb 28, 2018
Flexfrost Protein Ice Cream Mint Chip Flexfrost L.L.C recall — FDA F-0818-2018
The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
Class IIFDA: TerminatedFlexfrost
DrugFeb 28, 2018
American Pharmaceutical Ingredients Levocetirizine Dihydrochloride for prescription recall — FDA D-0503-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Itraconazole USP (Micronized) for prescription recall — FDA D-0497-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Ascorbic Acid USP, for prescription compounding recall — FDA D-0535-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Fluconazole USP for prescription compounding recall — FDA D-0492-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Progesterone USP (Micronized) (Yam) for prescription recall — FDA D-0518-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Diphenhydramine HCl USP f recall — FDA D-0485-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Ketoprofen USP (Micronized) for prescription compounding recall — FDA D-0500-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Anastrozole USP for prescription compounding recall — FDA D-0475-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Fluticasone propionate USP (Micronized) for prescription recall — FDA D-0539-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
DrugFeb 28, 2018
American Pharmaceutical Ingredients Imiquimod USP for prescription compounding recall — FDA D-0496-2018
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class IIFDA: TerminatedAmerican Pharmaceutical Ingredients LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.