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

3826–3850 of 13512

HighFDA (Devices)·Z-1191-2025·2025-02-26
RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2025·2025-02-26
RayStation radiation therapy software recall for density calculation inconsistency
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1194-2025·2025-02-26
Medical device recall: RayStation radiation therapy software dose calculation inconsistency
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1074-2025·2025-02-19
Sevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk
A sevoflurane vaporizer component may degrade to hydrogen fluoride, causing respiratory damage and chemical burns to patients and workers. FDA classified this Class I recall affecting six units in Kentucky and Connecticut.
Product
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1117-2025·2025-02-19
Wheelchair Power Assist Speed Control Dial Recalled for Loss of Control Risk
Max Mobility Smart Drive MX2+ SpeedControl Dial wheelchairs are being recalled due to faulty circuit boards that may cause loss of device control, potentially resulting in injury to users.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1116-2025·2025-02-19
Wheelchair Speed Control Remote Recalled Due to Loss-of-Control Risk
The Smart Drive MX2+ SpeedControl Dial remote is being recalled due to a faulty circuit board that could cause loss of control of the wheelchair power assist, potentially resulting in injury.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1071-2025·2025-02-19
Olympus Guide Sheath Kits recalled for potential radiopaque tip detachment
Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.
Product
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2025·2025-02-19
Novation XLE hip implant components recalled for missing barrier layer
Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.
Product
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1165-2025·2025-02-19
Exactech AcuMatch XLE Hip Implants Recalled Due to Missing Protective Barrier Layer
Exactech recalled AcuMatch XLE hip implants due to the absence of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Approximately 42 units were distributed in the U.S. and internationally.
Product
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1168-2025·2025-02-19
MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.
Product
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1162-2025·2025-02-19
Elekta MOSAIQ Oncology Information System: Incorrect Image Offset Calculations
Elekta is recalling MOSAIQ Oncology Information System software that may produce incorrect image offsets for Linear Accelerators not characterized at IEC61217 scale.
Product
MOSAIQ Oncology Information System
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1127-2025·2025-02-19
Cardinal Health Presource Kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1141-2025·2025-02-19
Spore Test Monitoring System Printing Error May Cause Result Misdirection
HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.
Product
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1130-2025·2025-02-19
Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.
Product
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2025·2025-02-19
Stryker Precision Thin surgical blade attachments recalled for specification defect
Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.
Product
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1126-2025·2025-02-19
Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2025·2025-02-19
Medical laser device recalled for inadequate safety operating instructions
Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.
Product
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2025·2025-02-19
Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.
Product
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2025·2025-02-19
BD Pyxis MedStation ES Medication Cabinet Drawer and Door Failures Recalled
The FDA is recalling BD Pyxis MedStation ES medication cabinets due to potential drawer and door failures that could delay medication access. Affected healthcare facilities should check their devices and contact the manufacturer if malfunctions occur.
Product
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2025·2025-02-19
Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination
Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.
Product
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1169-2025·2025-02-19
Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.
Product
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2025·2025-02-19
Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures
Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.
Product
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1132-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.
Product
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2025·2025-02-19
Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk
Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.
Product
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

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3826–3850 of 13512