Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

17051–17075 of 40124

HighFDA (Devices)·Z-2284-2020·2020-06-17
Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.
Product
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2020·2020-06-17
Canon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts
Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.
Product
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2020·2020-06-17
Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.
Product
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2020·2020-06-17
Genicon Natura Trocar Handle Recall Due to Detaching Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-152 trocar handles because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2339-2020·2020-06-17
RayStation Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.
Product
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2020·2020-06-17
Siemens Artis X-Ray Systems Recalled for Electrical Contact Issues
Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.
Product
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2020·2020-06-17
Canon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts
Canon Medical System is recalling 15 Infinix-8000F digital radiography systems because loose bolts may cause the catheterization table to tilt.
Product
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2020·2020-06-17
Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk
Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.
Product
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2020·2020-06-17
Biomet Recalls Comprehensive VRS Inserter Shoulder Prosthesis Devices
Biomet is recalling 38 Comprehensive VRS Inserter shoulder prosthesis devices because the central screw drill may seize, potentially extending surgery time.
Product
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2020·2020-06-17
Genicon GENILook Cannula Recalled Due to Detaching Optical Tip
Genicon, Inc. is recalling GENILook Model 200-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2344-2020·2020-06-17
RayStation 8A Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.
Product
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2269-2020·2020-06-17
Genicon GENILook Cannula Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-005-251 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2313-2020·2020-06-17
Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2357-2020·2020-06-17
BD FACS Sample Prep Assistant II Upgrade Recalled for Probe Wear
Becton, Dickinson and Company is recalling 51 units of the BD FACS Sample Prep Assistant II Upgrade due to premature probe wear that may cause sample dispensing issues.
Product
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2020·2020-06-17
Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference
Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.
Product
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2286-2020·2020-06-17
Ormco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error
Ormco/Sybronendo is recalling 2,189 units of Damon Q2 Orthodontic Metal Brackets because the bracket torque was mislabeled on the packaging.
Product
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2292-2020·2020-06-17
Olympus ENF-GP2 Fiberscope Recalled for Missing O Ring
Olympus is recalling 19 ENF-GP2 Rhino-Laryngo Fiberscopes because they may be missing an O ring after being repaired with an incorrect service manual.
Product
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2312-2020·2020-06-17
Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2315-2020·2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2303-2020·2020-06-17
Biomet 6.5 Cannulated Screw Tap Recalled for Incomplete Design History
Biomet is recalling 6.5 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.
Product
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2290-2020·2020-06-17
Qiagen Recalls EGFR PCR Kits Due to False Positive Risk
Qiagen is recalling 530 therascreen EGFR RGQ PCR Kits because a fluorescence artifact can cause rare false mutation positive results.
Product
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2307-2020·2020-06-17
Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2287-2020·2020-06-17
Alcon Recalls AcrySof IQ Intraocular Lenses Due to Incorrect Diopter
Alcon Research LLC is recalling 84 units of AcrySof IQ intraocular lenses because they have an incorrect diopter. The lenses were distributed nationwide.
Product
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2323-2020·2020-06-17
Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2308-2020·2020-06-17
Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History
Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide

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17051–17075 of 40124