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 27346

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-0599-2025·2024-12-11
Atellica CH β2-Microglobulin Reagent Produces Falsely Depressed Results
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
Product
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
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-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-0592-2025·2024-12-11
BD Phoenix M50 Automated Microbiology System Service Credentials Exposed
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
Product
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
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-0649-2025·2024-12-11
Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2025·2024-12-11
MEDLINE convenience kits recalled due to defective component
Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
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-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-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-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-0582-2025·2024-12-11
Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
Product
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Category
Medical Device
Distribution
0 states
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-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-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-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-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-0618-2025·2024-12-11
McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
Product
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0638-2025·2024-12-11
MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2025·2024-12-11
Fluoroscopic X-Ray System Hand Switch May Cause Unintended Radiation
Orthoscan Inc. is recalling 22 Ziehm Vision FD fluoroscopic x-ray systems. The hand switch may fail when dropped or impacted, potentially initiating unintended radiation exposure.
Product
Ziehm Vision FD. Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0600-2025·2024-12-11
GE Healthcare CT Systems May Display Rotated Images in Diagnostic Scans
Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.
Product
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Category
Medical Device
Distribution
0 states

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3626–3650 of 27346