FoodOct 10, 2018
Baker's Service of South Florida Coconut & Cheese Pastry recall — FDA F-0014-2019
Finished product labeling did not declare wheat.
Class IIFDA: TerminatedBaker's Service of South Florida, Inc.
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018373 records · 3 categoriesJanuary 2018162 records · 2 categories
2018 recalls — page 49
Records are ordered by the best available source date.
FoodOct 10, 2018
Oregon Heritage Developments Inc dba Oregon 100% Juice, 1 gallon plastic container, UPC: 8 recall — FDA F-0006-2019
Oregon Heritage Farms Family Blend Apple Cider, 1 gallon size, is recalled due to elevated level of patulin.
Class IIFDA: TerminatedOregon Heritage Developments Inc dba Oregon Heritage…
FoodOct 10, 2018
Lamb Weston Formed Hash Brown Patties, packaged in cardboard trays covered recall — FDA F-0001-2019
Hash brown product, sold under brands Brookshire's, Market Pantry, Breakfast, and Stater Bros, are recalled because the product may contain small fragments of hard, clear plastic.
Class IIFDA: TerminatedLamb Weston Inc.
FoodOct 10, 2018
Wismettac Asian Foods (USA) dba Nishimoto EVERYBURGER - Burger-Shaped Chocolate Cookies: NET recall — FDA F-0017-2019
The ingredient list and allergen information are partially covered by a nutrition sticker. Allergens of wheat, milk and eggs are visible.
Class IIFDA: TerminatedWismettac Asian Foods (USA) dba Nishimoto Trading Co…
FoodOct 10, 2018
Baker's Service of South Florida Guava Pastry recall — FDA F-0007-2019
Finished product labeling did not declare wheat and color additives (Yellow #6, Red #3, and Red #40).
Class IIFDA: TerminatedBaker's Service of South Florida, Inc.
DrugOct 10, 2018
Otsuka Pharmaceutical Development & treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA recall — FDA D-0017-2019
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be…
Class IIIFDA: TerminatedOtsuka Pharmaceutical Development & Commercialization,…
DrugOct 10, 2018
Otsuka Pharmaceutical Development & treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA recall — FDA D-0018-2019
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be…
Class IIIFDA: TerminatedOtsuka Pharmaceutical Development & Commercialization,…
DrugOct 10, 2018
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles recall — FDA D-0001-2019
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugOct 10, 2018
Sichuan Friendly Pharmaceutical Co Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan recall — FDA D-0006-2019
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class IIFDA: TerminatedSichuan Friendly Pharmaceutical Co., Ltd.
DrugOct 10, 2018
Endo Pharmaceuticals robaxin-750 recall — FDA D-0009-2019
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two…
Class IFDA: TerminatedEndo Pharmaceuticals, Inc.
DrugOct 10, 2018
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial recall — FDA D-0005-2019
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic…
Class IIFDA: TerminatedPfizer Inc.
DrugOct 10, 2018
Dr. Reddy's Laboratories Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & recall — FDA D-0007-2019
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugOct 10, 2018
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel recall — FDA D-0002-2019
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality…
Class IIFDA: TerminatedBioLyte Laboratories, LLC
Medical DeviceOct 3, 2018
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in recall — FDA Z-3212-2018
The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if…
Class IIFDA: TerminatedMedtronic Neurosurgery
Medical DeviceOct 3, 2018
Shockwave Medical The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced recall — FDA Z-3247-2018
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
Class IIFDA: TerminatedShockwave Medical, Inc.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F010, System Code 722003 Vascular, cardiovascular and recall — FDA Z-3227-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Reckitt Benckiser Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers recall — FDA Z-3241-2018
The products failed the filed specification of 1.0kPa for Burst Pressure.
Class IIFDA: TerminatedReckitt Benckiser LLC
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular recall — FDA Z-3224-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Boston Scientific VISIONIST X4 CRT-P recall — FDA Z-3259-2018
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery…
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceOct 3, 2018
Boston Scientific Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston recall — FDA Z-3260-2018
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceOct 3, 2018
Philips Electronics AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and recall — FDA Z-3229-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary recall — FDA Z-3242-2018
Screws on a Terumo Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular recall — FDA Z-3219-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular recall — FDA Z-3217-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
About the 2018 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.