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 deaths or serious injuries are reported, 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

2526–2550 of 39948

ModerateFDA (Devices)·Z-0545-2026·2025-11-26
Red serum separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 50,050 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0539-2026·2025-11-26
Clotting time cartridges recalled over dried blood on carton labels
Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0563-2026·2025-11-26
Balanced heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 121,750 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0544-2026·2025-11-26
Lithium heparin microtubes recalled over an inadequate quality system
ASP Global is recalling 78,000 SAFE-T-FILL micro capillary blood collection tubes, 125 microlitres with lithium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0553-2026·2025-11-26
Sodium fluoride microtubes recalled over an inadequate quality system
ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0555-2026·2025-11-26
Microhematocrit capillary tubes recalled over an inadequate quality system
ASP Global is recalling 2,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0543-2026·2025-11-26
Bronchoscopes recalled after leak testing with equipment outside its operating range
Auris Health is recalling 1,477 MONARCH Bronchoscopes because the product may have been leak tested using equipment operating outside its expected range.
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0551-2026·2025-11-26
Lithium heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 103,200 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0559-2026·2025-11-26
Untreated blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2026·2025-11-26
Capillary magnetic rings recalled over unvalidated manufacturing processes
ASP Global is recalling 16,920 SAFE-T-FILL magnetic rings for blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0536-2026·2025-11-26
Shoulder reamer 46mm recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0564-2026·2025-11-26
Capillary end caps recalled over an inadequate quality system
ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.
Product
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0534-2026·2025-11-26
Measles antibody tests recalled for being distributed without premarket clearance
Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.
Product
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presen
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0547-2026·2025-11-26
Clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0550-2026·2025-11-26
Plasma separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0549-2026·2025-11-26
Plasma separator microtubes recalled over an inadequate quality system
ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
Product
AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0560-2026·2025-11-26
Sodium heparin capillary tubes recalled over an inadequate quality system
ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2026·2025-11-26
Serum separator microtubes recalled over unvalidated manufacturing processes
ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0554-2026·2025-11-26
Amber clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0561-2026·2025-11-26
Larger sodium heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 947,100 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0537-2026·2025-11-26
Pilot tip converters recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.
Product
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0548-2026·2025-11-26
Three hundred microlitre clot activator tubes recalled over quality system findings
ASP Global is recalling 6,600 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2026·2025-11-26
Sodium heparin blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 160,250 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0567-2026·2025-11-26
Micro collection tube extenders recalled over an inadequate quality system
ASP Global is recalling 27,100 SAFE-T-FILL micro collection tube extenders over an inadequate quality system with unvalidated manufacturing processes.
Product
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0552-2026·2025-11-26
Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide

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2526–2550 of 39948