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

2476–2500 of 39824

HighFDA (Devices)·Z-0503-2026·2025-11-26
Oncology software recalled because appended medication orders may mismatch the schedule
Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2026·2025-11-26
Blood tubes recalled after being manufactured without the gel separator
Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.
Product
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0533-2026·2025-11-26
Hemostasis valves recalled because the valve cap may remain depressed
Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.
Product
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0528-2026·2025-11-26
LEEP procedure packs recalled over smoke pencils that may self activate
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2026·2025-11-26
Central line and flap packs recalled over smoke pencils that may activate
Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2026·2025-11-26
Gynecology and robotic kits recalled over smoke pencils that may self activate
Medline is recalling 2,844 gynecology laparoscopy and robotic convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2026·2025-11-26
Heart pump controllers recalled over corrosion at the backup battery connector
Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0568-2026·2025-11-26
C difficile test kits recalled over buffer caps missing a gasket
Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
Product
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0542-2026·2025-11-26
Cell morphology analyzers recalled over barcodes read from the previous slide
Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0508-2026·2025-11-26
HeartMate II controllers recalled over corrosion at the battery connector
Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
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-0535-2026·2025-11-26
Shoulder reamers recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Category
Medical Device
Distribution
1 state
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
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-0566-2026·2025-11-26
Capillary mixing fleas recalled over an inadequate quality system
ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
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-0557-2026·2025-11-26
Blood gas capillary tubes recalled over an inadequate quality system
ASP Global is recalling 397,000 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres, because they were manufactured under an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-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

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