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

17276–17300 of 40287

HighFDA (Devices)·Z-2114-2020·2020-06-03
Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation
Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
Product
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290)…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2102-2020·2020-06-03
Cardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking
Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2143-2020·2020-06-03
Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk
Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.
Product
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2020·2020-06-03
Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels
Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2020·2020-06-03
Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures
Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.
Product
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2139-2020·2020-06-03
Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.
Product
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2020·2020-06-03
Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.
Product
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2020·2020-06-03
Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.
Product
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2020·2020-06-03
Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.
Product
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2020·2020-06-03
Cardinal Health Recalls Kangaroo 924 Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo 924 Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2159-2020·2020-06-03
Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.
Product
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-2132-2020·2020-06-03
Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.
Product
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2020·2020-06-03
Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns
Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.
Product
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2020·2020-06-03
Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo Joey Safety Screw Spike sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2133-2020·2020-06-03
Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.
Product
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2020·2020-06-03
MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk
MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.
Product
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2020·2020-06-03
Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets
Cardinal Health is recalling Kangaroo Joey Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2162-2020·2020-06-03
Sonendo GentleWave Foot Pedal Recall Due to Extended Console Operation
Sonendo Inc is recalling 460 GentleWave foot pedals because the console may continue running for an extended period after the pedal is released.
Product
GENTLEWAVE REF: FG-002-0001
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2149-2020·2020-06-03
Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2020·2020-06-03
Applied Medical Resources Recalls Laparoscopic Graspers Due to Tissue Damage Risk
Applied Medical Resources Corp is recalling 21 units of Dr. Thames Lap Chole laparoscopic graspers because a protruding rivet may cause tissue damage during use.
Product
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-2144-2020·2020-06-03
Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels
Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.
Product
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2020·2020-06-03
Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets
Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2152-2020·2020-06-03
Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels
Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2020·2020-06-03
Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels
Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.
Product
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2020·2020-06-03
Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction
Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.
Product
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
Category
Medical Device
Distribution
Distributed nationwide

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17276–17300 of 40287