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

7826–7850 of 13652

HighFDA (Devices)·Z-0493-2024·2023-12-13
Integra Cranial Access Kit packaging defect compromises device sterility
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Product
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2024·2023-12-13
TENS Devices Recalled for Missing Instruction Manual Warnings
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
Product
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0500-2024·2023-12-13
Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
Product
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0469-2024·2023-12-13
EVO VISIAN Intraocular Lens Recalled Due to Specification Concerns
Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.
Product
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-0479-2024·2023-12-13
HeartWare HVAD Implant Kit Instructional Update for Fault Alarms
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
Product
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0487-2024·2023-12-13
Remington Medical drainage bags recalled due to packaging label date error
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.
Product
Remington MEDICAL Drainage Bag, REF 600-D;
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0475-2024·2023-12-13
HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
Product
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0481-2024·2023-12-13
Ventricular Assist Device Instructions Updated for Alarm and Useful Life Clarification
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Product
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0488-2024·2023-12-13
Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0470-2024·2023-12-13
Intraocular Lens Devices May Not Meet Manufacturing Specifications
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-0451-2024·2023-12-13
Blood Culture Identification Panel Quality Control Test Reporting Issue
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2024·2023-12-06
Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
Product
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0414-2024·2023-12-06
Edwards TruWave pressure monitoring kit recalled for setup issues
Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.
Product
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0421-2024·2023-12-06
Medtronic Insertable Cardiac Monitor May Fail to Record Heart Rhythms
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
Product
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0405-2024·2023-12-06
Breas Medical Ventilator Mouthpiece Recall: Unintended Slits May Reduce Ventilation
Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.
Product
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2024·2023-12-06
FloTrac Sensor Recalled Due to Potential Flushing Difficulties During Setup
Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.
Product
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0416-2024·2023-12-06
Improperly Repaired Gastrointestinal Videoscope May Expose Patients to Contamination
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
Product
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0419-2024·2023-12-06
Olympus EVIS EXERA III Colonoscope Recall for Connector Defect
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.
Product
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0418-2024·2023-12-06
Colonoscope Repair Defect May Cause Device Malfunction and Contamination Risk
Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.
Product
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0423-2024·2023-12-06
RAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings
Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.
Product
RAPIDPOINT 500 Blood Gas System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0409-2024·2023-12-06
Acumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty
Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.
Product
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0401-2024·2023-12-06
SENTIERO Hearing Examination Device Recalled for Technical Distortions
PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.
Product
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0400-2024·2023-12-06
BD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly
BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.
Product
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0407-2024·2023-12-06
Abbott Alinity m HCV Kit Recalled for False Positive Results
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
Product
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in hum
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0415-2024·2023-12-06
Olympus colonoscope repair defect may impair imaging and suction function
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
Product
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Category
Medical Device
Distribution
6 states

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7826–7850 of 13652