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

3626–3650 of 27375

HighFDA (Devices)·Z-0621-2025·2024-12-11
BD Bacterial Susceptibility Test Discs Recall for Decreased Potency
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.
Product
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2025·2024-12-11
Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Product
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0611-2025·2024-12-11
GE Healthcare CT System May Produce Rotated Diagnostic Images
GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.
Product
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0603-2025·2024-12-11
GE Healthcare Revolution ACE CT Systems Image Rotation Issue
GE Healthcare's Revolution ACE CT systems can produce progressively rotated images during certain scan modes. Maximum rotation reaches 56 degrees, potentially affecting diagnostic interpretation.
Product
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0612-2025·2024-12-11
GE Healthcare CT systems produce progressively rotated images in scan modes
Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.
Product
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0607-2025·2024-12-11
GE Healthcare CT Imaging System May Produce Rotated Medical Images
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.
Product
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0586-2025·2024-12-11
Medical Device Data Management Software Affected by Unauthorized Service Credential Access
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
Product
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0575-2025·2024-12-11
X-ray system hand switch may fail, risking unintended radiation exposure
Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.
Product
Ziehm Vision system, x-ray, tomography, computed.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0610-2025·2024-12-11
GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation
GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.
Product
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0601-2025·2024-12-11
GE Healthcare Optima 520 CT systems recalled for image rotation
GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.
Product
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0524-2025·2024-12-11
Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure
Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.
Product
Fusion Pro 24, Model 17000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2025·2024-12-11
Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation
Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.
Product
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0615-2025·2024-12-11
GE Healthcare CT Operator Console Update: Images May Rotate Progressively
GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.
Product
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0595-2025·2024-12-11
BACTEC 9120 System Recalled Due to Compromised Service Credentials
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
Product
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0620-2025·2024-12-11
Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2025·2024-12-11
Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation
The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.
Product
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0604-2025·2024-12-11
CT imaging systems may display progressively rotated images in certain scan modes
Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.
Product
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0589-2025·2024-12-11
BD COR GX Instrument recalled due to compromised service credentials
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
Product
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0590-2025·2024-12-11
Medical Device: BD MAX System Service Credential Breach Poses Unauthorized Access Risk
An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.
Product
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2025·2024-12-11
MEDLINE circumcision kits recalled due to defective smoke evacuation component
MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.
Product
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2025·2024-12-11
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0647-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled Due to Defective Smoke Evacuation Equipment
Medline is recalling surgical convenience kits that contain defective smoke evacuation pencils previously recalled by Stryker. The 478 affected units were distributed nationwide; healthcare facilities should discontinue use immediately and contact Medline for instructions.
Product
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2025·2024-12-11
BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
Product
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0606-2025·2024-12-11
CT imaging system issue causes progressive image rotation during scans
GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.
Product
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0598-2025·2024-12-11
Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates
Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.
Product
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Category
Medical Device
Distribution
Distributed nationwide

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3626–3650 of 27375