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 27327

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-2996-2026·2026-09-02
Medline Neurosponge Kits Recalled for Endotoxin Levels
Medline is recalling 3,468 neurosurgical convenience kits containing Pilling Wecksorb Neurosponges due to potential out-of-specification endotoxin levels.
Product
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I;
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-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-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-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-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-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-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
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-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-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-2987-2026·2026-08-26
restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.
Product
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2872-2026·2026-08-26
BD Needle Kit for Powered Driver Recall Due to Removal Difficulty
Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.
Product
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Dr
Category
Medical Device
Distribution
32 states
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-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-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-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-2953-2026·2026-08-26
Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
Intersurgical Inc is recalling 1,575 One-Piece Guedel Airway devices because they could potentially be occluded or partially occluded.
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2986-2026·2026-08-26
ConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
ConvaTec is recalling Esteem Body Soft Convex Urostomy Pouches because they may leak from the cap during use.
Product
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
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-2961-2026·2026-08-26
Boston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
Boston Scientific is recalling OverStitch Suture Cinch devices because they may fail to deploy the implant or cut the suture as intended.
Product
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Category
Medical Device
Distribution
Distributed nationwide
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

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