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

1476–1500 of 27346

HighFDA (Devices)·Z-1099-2026·2026-01-21
Circulatory support blood pumps recalled over locking into the motor
Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.
Product
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System
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-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-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-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-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-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-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-1092-2026·2026-01-21
Patient positioning systems recalled over stereotactic radiosurgery tolerance errors
C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.
Product
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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
CriticalFDA (Devices)·Z-1002-2026·2026-01-14
Mini Plus surgical kits recalled as not suitable for organ transplant
AVID Medical is recalling 380 Halyard Mini Plus Kit South units because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
Product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1001-2026·2026-01-14
Organ recovery surgical packs recalled as not suitable for organ transplant
AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1000-2026·2026-01-14
Organ recovery packs recalled as not suitable for organ transplant
AVID Medical is recalling 132 Halyard Organ Recovery OR Packs, kit code LLOG1000-15, because the devices are not suitable for organ transplant.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2026·2026-01-14
C. difficile assay recalled over declining performance and false negative results
Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2026·2026-01-14
Emergency call stations recalled over missing low battery alerts
Securitas Healthcare is recalling 1,898 Arial 900 MHz Call Stations, model CSK200-900MR, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.
Product
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2026·2026-01-14
Thyroid receptor immunoassay recalled over variable results across instrument platforms
Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or treatment.
Product
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocompl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2026·2026-01-14
Patient monitors recalled over unvalidated intracranial and bladder pressure measurements
Remote Diagnostic Technologies is recalling 7,129 Philips Tempus Pro Patient Monitors because intracranial and bladder pressure measurements have not been tested or validated for accuracy.
Product
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2026·2026-01-14
Telemetry monitors recalled over a failure to reconnect between access points
Philips North America is recalling 13,470 Smart-hopping 2.0 AP 1.4 GHz patient monitors because the MX40 could not reconnect to the PIC iX when signal strength changed quickly.
Product
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2026·2026-01-14
Oxygen masks recalled after complaints of tubing disconnecting during use
Medline is recalling 1,611,081 Hudson RCI medium concentration oxygen masks after multiple complaints of tubing disconnecting, which may lead to shortness of breath and hypoxia.
Product
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2026·2026-01-14
Medication dispensing servers recalled over delayed updates from enterprise systems
CareFusion 303 is recalling 2,079 BD Pyxis ES Enterprise Server systems over a software issue that may result in equipment not receiving timely updates of patient or medication information.
Product
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2026·2026-01-14
Arial call stations recalled over a firmware issue affecting battery alerts
Securitas Healthcare is recalling 5,627 Arial 900 MHz Call Stations, model CSK200-900, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.
Product
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2026·2026-01-14
Head fixation devices recalled because a torque screw may crack or separate
IMRIS Imaging is recalling 122 HFD100 Head Fixation Devices because a torque screw may crack or separate, which could lead to inadequate head stabilization and risk of patient injury.
Product
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal
Category
Medical Device
Distribution
Distributed nationwide

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1476–1500 of 27346