Medical DeviceSep 13, 2023
PARAGON VISION SCIENCES Fargo Ortho-K Lens recall — FDA Z-2516-2023
Manufactured lenses are not covered by existing FDA approval
Class IIFDA: OngoingPARAGON VISION SCIENCES, Inc.
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 45
Records are ordered by the best available source date.
Medical DeviceSep 13, 2023
Diversatek Healthcare ZVU Functional GI Software, REF: ZVU-3 recall — FDA Z-2521-2023
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Class IIIFDA: OngoingDiversatek Healthcare
Medical DeviceSep 13, 2023
Zimmer M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 recall — FDA Z-2519-2023
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceSep 13, 2023
Aomori Olympus Co Olympus Distal Attachment recall — FDA Z-2522-2023
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Class IIFDA: OngoingAomori Olympus Co., Ltd.
Medical DeviceSep 13, 2023
PARAGON VISION SCIENCES ISee Ortho-K Lens recall — FDA Z-2515-2023
Manufactured lenses are not covered by existing FDA approval
Class IIFDA: OngoingPARAGON VISION SCIENCES, Inc.
FoodSep 13, 2023
Nestle-USA Nestle Toll House, Chocolate Chip Cookie Dough, 16.5 oz recall — FDA F-1491-2023
Potential presence of wood fragments.
Class IIFDA: TerminatedNestle-USA, Inc. (Corporate Office)
FoodSep 13, 2023
PBM Nutritionals Parent's Choice brand Sensitivity Premium Infant Formula recall — FDA F-1493-2023
Inadvertent release of rejected product to market
Class IIIFDA: TerminatedPBM Nutritionals, LLC
FoodSep 13, 2023
Cooperstown Cheese Company 1 recall — FDA F-1490-2023
Cheese may be contaminated with Listeria monocytogenes.
Class IIFDA: TerminatedCooperstown Cheese Company, LLC
DrugSep 13, 2023
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet recall — FDA D-1145-2023
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class IIIFDA: TerminatedAscend Laboratories, LLC
DrugSep 13, 2023
Marlex Pharmaceuticals Digoxin Tablets, USP 0.125mg, 100-count bottles recall — FDA D-1169-2023
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP…
Class IFDA: TerminatedMarlex Pharmaceuticals, Inc.
DrugSep 13, 2023
Marlex Pharmaceuticals Digoxin Tablets, USP 0.25mg, 100-count bottles recall — FDA D-1170-2023
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP…
Class IIFDA: TerminatedMarlex Pharmaceuticals, Inc.
DrugSep 13, 2023
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus recall — FDA D-1146-2023
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription…
Class IIFDA: TerminatedAVKARE LLC
DrugSep 13, 2023
Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. recall — FDA D-1147-2023
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class IIFDA: TerminatedAVKARE LLC
DrugSep 13, 2023
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL) recall — FDA D-1144-2023
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedCaplin Steriles Limited
VehicleSep 8, 2023
Ford traction battery recall — NHTSA campaign 23V626000
Ford Motor Company (Ford) is recalling certain 2020-2022 Lincoln Aviator and Ford Explorer vehicles equipped with 3.0L PHEV engines. A manufacturing defect in one or more of the high…
traction batteryFord Motor Company
VehicleSep 8, 2023
Nissan camera recall — NHTSA campaign 23V628000
Nissan North America, Inc. (Nissan) is recalling certain 2019-2021 Altima and 2020-2021 Sentra vehicles. Damage to the camera harness can cause distortion or loss of the rearview camera…
cameraNissan North America, Inc.
Medical DeviceSep 6, 2023
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31 recall — FDA Z-2486-2023
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Class IIFDA: OngoingDatascope Corp.
Medical DeviceSep 6, 2023
RAYSEARCH LABORATORIES AB RayCare software, include version number 5A, 5B, 6A, including recall — FDA Z-2464-2023
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceSep 6, 2023
Siemens Healthcare Diagnostics epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS recall — FDA Z-2476-2023
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Class IIFDA: OngoingSiemens Healthcare Diagnostics Inc.
Medical DeviceSep 6, 2023
Accuray Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the recall — FDA Z-2489-2023
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while…
Class IIFDA: CompletedAccuray Inc.
Medical DeviceSep 6, 2023
Oculus Pentacam AXL Wave, Ref 70020, CE 0123 recall — FDA Z-2482-2023
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Class IIFDA: OngoingOculus Optikgeraete GMBH
Medical DeviceSep 6, 2023
Datascope Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75 recall — FDA Z-2436-2023
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there…
Class IFDA: OngoingDatascope Corp.
Medical DeviceSep 6, 2023
Siemens Healthcare Diagnostics epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW recall — FDA Z-2478-2023
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Class IIFDA: OngoingSiemens Healthcare Diagnostics Inc.
Medical DeviceSep 6, 2023
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 recall — FDA Z-2488-2023
Lipemic interference failed to meet the performance specification listed within the IFU.
Class IIFDA: OngoingBeckman Coulter Inc.
About the 2023 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.