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

1–25 of 39760

SevereFDA (Devices)·Z-2993-2026·2026-09-02
Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
Medline is recalling neonatal and infant heated wire breathing circuits due to a risk of sporadic failure and thermal damage at the humidifier connector.
Product
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007K
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2991-2026·2026-09-02
Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Failure
Medline is recalling 20 units of neonatal heated wire breathing circuits due to potential thermal damage that could cause airway obstruction or respiratory distress in infants.
Product
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3032-2026·2026-09-02
Healthmark Protein Test Recalled Due to Expired Ingredient
Healthmark is recalling ProChek protein tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Product
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
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-3021-2026·2026-09-02
Medline Head and Neck Kits Recalled for Contaminated Component
Medline is recalling 24 convenience kits labeled as MAJOR HEAD AND NECK PPS because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Category
Medical Device
Distribution
Distributed nationwide
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-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-3014-2026·2026-09-02
Canon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.
Product
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the he
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
HighFDA (Devices)·Z-3027-2026·2026-09-02
Medline Recalls Surgical Convenience Kits Due to Contaminated Components
Medline Industries is recalling 169 surgical convenience kits nationwide because they contain potentially contaminated components.
Product
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3005-2026·2026-09-02
Halyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
AVID Medical is recalling 45 Halyard DAVINCI TRUCUSTOM Foley catheter kits because the labeling fails to identify that the statlock component contains natural rubber latex.
Product
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2994-2026·2026-09-02
Medline Medical Convenience Kits Recalled for Endotoxin Levels
Medline Industries is recalling 2,262 medical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
Product
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU
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-3033-2026·2026-09-02
IMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.
Product
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Category
Medical Device
Distribution
Distributed nationwide
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-3031-2026·2026-09-02
Healthmark ProChek-II Medical Tests Recalled for Expired Ingredient
Healthmark Industries is recalling ProChek-II tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3034-2026·2026-09-02
IMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
IMRIS Imaging Inc is recalling 13 ORT300 operating room tables because a mechanical failure could cause unintended rotational movement, posing a risk of injury to patients.
Product
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3038-2026·2026-09-02
GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
GE Medical Systems is recalling 15 units of Portrait Core Services Software V1.0.5 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
Product
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Category
Medical Device
Distribution
2 states
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-3012-2026·2026-09-02
Midmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.
Product
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3028-2026·2026-09-02
Medline Recalls 419 Surgical Kits Due to Contaminated Component
Medline Industries is recalling 419 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide.
Product
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3020-2026·2026-09-02
Medline Recalls 263 Surgical Convenience Kits Due to Contamination
Medline Industries is recalling 263 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide in 18 states.
Product
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3013-2026·2026-09-02
Midmark Digital ECG Software Recall for Incorrect Waveform Display
Midmark is recalling Digital ECG HD+12 and HD+15 units with specific IQecg plugin software versions due to a communication anomaly that may cause incorrect ECG waveforms and inaccurate heart rate calculations.
Product
Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3019-2026·2026-09-02
Medline Recalls 71 Convenience Kits Due to Contaminated Component
Medline Industries is recalling 71 FEMORAL PACK and FEVAR convenience kits because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2998-2026·2026-09-02
Hollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
Hollister is recalling specific lots of Onli hydrophilic urethral intermittent catheters because a manufacturing defect may cause a protrusion that leads to genitourinary trauma or bleeding.
Product
Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral In
Category
Medical Device
Distribution
Distributed nationwide

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