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

2001–2025 of 39948

HighFDA (Devices)·Z-1082-2026·2026-01-21
Swan rubbing alcohol recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Swan White Clear Alcohol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1024-2026·2026-01-21
Pepto Bismol recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Pepto Bismol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1078-2026·2026-01-21
Oncology information system recalled over a potential for overtreatment
Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.
Product
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2026·2026-01-21
Lucky Ice mouthwash recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2026·2026-01-21
Motrin dispensers recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Motrin 2's dispensers over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
MAXXUS, System, Tomography, Computed, Emission
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1098-2026·2026-01-21
Venous stents recalled over a nitinol anomaly that reduces deployed diameter
Medtronic is recalling 442 Abre Venous Self-Expanding Stent Systems because a nitinol anomaly causes a reduced stent diameter and radial force when deployed, which may result in migration.
Product
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2026·2026-01-21
MRI systems recalled over ice that may block the magnet venting system
Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.
Product
Allura Xper FD20 Biplane; Model Number: 722013;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2026·2026-01-21
Surgical access port kits recalled over trays that may crack
Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2026·2026-01-21
Levothyroxine tablets recalled after a bottle held the wrong strength
Alvogen is recalling a lot of Levothyroxine Sodium Tablets, 150mcg, after a pharmacy reported a single bottle containing 88 mcg tablets instead of 150 mcg tablets.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) P
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1044-2026·2026-01-21
SMV DSX New Line systems recalled over a potential detector fall
GE HealthCare is recalling 7 units of the SMV DSX New Line nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Product
SMV DSX New Line, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1058-2026·2026-01-21
Children's NyQuil recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Children's NyQuil Cold & Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2026·2026-01-21
Arterial blood sampling kits recalled over a crack on the syringe collar
ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.
Product
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2026·2026-01-21
Advil products recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Advil products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
SMV BodyTrack, System, Tomography, Computed, Emission
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1094-2026·2026-01-21
Infusion pumps recalled over speakers that may not produce audible alarms
ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.
Product
Plum Duo Infusion System, List Number 40002-04-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2026·2026-01-21
Cell wash solution recalled over fungal contamination of an affected lot
Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2026·2026-01-21
SMV DSI nuclear medicine systems recalled over a potential detector fall
GE HealthCare is recalling 3 units of the SMV DSI nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Product
SMV DSI, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1018-2026·2026-01-21
MRI systems recalled over ice that may block magnet venting
Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.
Product
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2026·2026-01-21
Spinal tray syringes recalled over a crack on the syringe collar
ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.
Product
Portex Spinal Tray, Item No. A3729-24 A3595
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1055-2026·2026-01-21
IV supply drawers recalled over recalled B. Braun administration sets inside
Medline is recalling 3045 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1038-2026·2026-01-21
Universal implant inserters recalled because the rotation tool handle can untread
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1085-2026·2026-01-21
Robotic thoracic and cardiac kits recalled over leaking suction irrigators
Medline is recalling 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Product
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1089-2026·2026-01-21
Hysterectomy procedure kits recalled over leaking suction irrigators inside
Medline is recalling 1457 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Product
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2026·2026-01-21
Allura Xper FD10C systems recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 38 Allura Xper FD10C systems because the drip tray beneath the cooling unit may not have been installed.
Product
Product Name: Allura Xper FD10C; Model number: 722001;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1070-2026·2026-01-21
Surgical procedure packs recalled over recalled B. Braun administration sets inside
Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Product
Allura Xper FD20; Model Number: 722012;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1068-2026·2026-01-21
Allura Xper FD10, model 722026, recalled over a missing cooling unit drip tray
Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.
Product
Allura Xper FD10; Model Number: 722010;
Category
Medical Device
Distribution
Distributed nationwide

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2001–2025 of 39948