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

4351–4375 of 13543

HighFDA (Devices)·Z-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
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
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-0608-2025·2024-12-11
GE Healthcare CT Systems Recalled Due to Progressive Image Rotation
GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.
Product
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
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-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-0622-2025·2024-12-11
Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2025·2024-12-11
Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.
Product
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2025·2024-12-11
Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation
The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.
Product
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Category
Medical Device
Distribution
0 states
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
0 states
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-0627-2025·2024-12-11
Medline Medical Device Kits Recalled Due to Defective SafeAir Component
Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, RE
Category
Medical Device
Distribution
Distributed nationwide
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
HighFDA (Devices)·Z-0605-2025·2024-12-11
GE Healthcare Revolution Ascend CT System Recalled for Image Rotation
GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.
Product
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0597-2025·2024-12-11
Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results
Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.
Product
Atellica CI Analyzer. Catalog Numbers: 10947347.
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-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-0626-2025·2024-12-11
Medline recalls surgical convenience kits with defective smoke evacuation component
Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.
Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
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-0619-2025·2024-12-11
Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in Illinois, Texas, and Virginia.
Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP 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-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-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-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-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

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4351–4375 of 13543