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

5026–5050 of 39844

ModerateFDA (Devices)·Z-0652-2025·2024-12-18
ICU Medical ChemoLock Closed System Transfer Device Packaging Recall
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
Product
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytoto
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0669-2025·2024-12-18
Hologic Sizer Set Missing Instructions for Use and Sterilization
Hologic is recalling 178 units of Sizer Set surgical instruments nationwide because instructions for use and revised sterilization instructions were not provided with the product.
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0651-2025·2024-12-18
Small DKS Disposable Kerrison System Inadvertently Distributed
Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.
Product
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
Category
Medical Device
Distribution
5 states
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-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-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-0630-2025·2024-12-11
Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
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-0574-2025·2024-12-11
X-ray system hand switch may fail under mechanical stress
The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.
Product
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0631-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Product
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.
Product
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
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-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-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-0632-2025·2024-12-11
MEDLINE Port Insertion Pack Recalled for Defective Component
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0573-2025·2024-12-11
Mobile C-arm hand switch defect may cause unintended X-ray emission
Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.
Product
Ziehm Solo. Digital Mobile C-arm
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0613-2025·2024-12-11
GE Healthcare CT Operator Console Images May Rotate During Scans
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.
Product
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; 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-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-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-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
1 state
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-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-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-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

How to read this listing

Filters

5026–5050 of 39844