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

26–50 of 27298

HighFDA (Devices)·Z-2992-2026·2026-09-02
Medline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
Medline is recalling 145,525 neonatal and infant heated wire breathing circuits due to potential thermal damage that could cause airway obstruction.
Product
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3039-2026·2026-09-02
GE Medical Systems Recalls Portrait Core Services Software Reload Unit
GE Medical Systems is recalling a software reload unit for the Portrait Core Services system due to a defect that may cause loss of patient monitoring and reset alarm settings.
Product
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-3023-2026·2026-09-02
Medline Convenience Kits Recalled for Potentially Contaminated Component
Medline Industries is recalling 15 convenience kits (SKU CDS980375M) due to a potentially contaminated component. The kits were distributed in 18 US states.
Product
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3026-2026·2026-09-02
Medline C-Section Convenience Kits Recalled for Contaminated Components
Medline Industries is recalling 106 C-section convenience kits distributed nationwide due to potentially contaminated components.
Product
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3017-2026·2026-09-02
Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.
Product
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3025-2026·2026-09-02
Medline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
Medline Industries is recalling 1,349 gynecologic robotic surgery kits nationwide because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3029-2026·2026-09-02
Medline Recalls Neurosurgical Convenience Kits Due to Contamination
Medline Industries is recalling 241 neurosurgical convenience kits distributed nationwide because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3004-2026·2026-09-02
Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
Merge Healthcare is recalling 20 Merge PACS and Merge OrthoPACS workstations because a software issue may cause measurements to be displayed inaccurately.
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2988-2026·2026-09-02
Philips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
Philips is recalling Incisive CT scanners with specific software versions due to a potential failure to trigger clinical scans during bolus tracking.
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2960-2026·2026-08-26
Tobii Dynavox Recalls TD Navio Maxi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Maxi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Product
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2981-2026·2026-08-26
Medtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
Medtronic is recalling seven MiniMed 670G insulin pumps because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.
Product
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2976-2026·2026-08-26
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
Product
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2959-2026·2026-08-26
Tobii Dynavox Recalls TD Navio Midi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Midi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Product
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2975-2026·2026-08-26
Siemens Quinidine Assay Recalled for Precision Errors
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2964-2026·2026-08-26
AVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
AVID Medical, Inc. is recalling 40 packs of Halyard LAVH PACK kits because a component was improperly sterilized, potentially causing leaks.
Product
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2978-2026·2026-08-26
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.
Product
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2982-2026·2026-08-26
Medtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk
Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.
Product
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2956-2026·2026-08-26
Philips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
Philips is recalling 1,810 Cardiac Workstation 7000 units because they may intermittently provide inaccurate native heart rate data.
Product
Cardiac Workstation 7000. Product Number: 860441.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2954-2026·2026-08-26
Dentsply Sirona Capsule Mixer Recalled for Electrical Discharge Risk
SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.
Product
Dentsply Sirona Capsule Mixer Model No. 5546068
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-2955-2026·2026-08-26
Philips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
Philips is recalling 796 Cardiac Workstation 5000 units worldwide because they may intermittently provide inaccurate native heart rate data.
Product
Cardiac Workstation 5000. Product Number: 860439.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2970-2026·2026-08-26
Gentherm Medical Recalls Blanketrol III Thermal Regulating Systems
Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Product
Blanketrol III, Model 233; Thermal regulating system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2952-2026·2026-08-26
Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.
Product
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2966-2026·2026-08-26
Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2983-2026·2026-08-26
Fort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect
Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.
Product
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2967-2026·2026-08-26
Paragonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect
Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.
Product
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

26–50 of 27298