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

6076–6100 of 27364

HighFDA (Devices)·Z-1176-2024·2024-02-28
Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk
Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.
Product
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2024·2024-02-28
Radiation Oncology Treatment Planning Software VERIQA Calculation Error
PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.
Product
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1143-2024·2024-02-28
Ionolux dental cement recalled for manufacturing defect affecting curing
Ionolux dental cement capsules may contain incorrect plungers that prevent proper curing. Affected batches distributed in the US and internationally should not be used.
Product
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1155-2024·2024-02-28
X-ray fluoroscopy system may display abnormal images due to detector board defect
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
Product
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1147-2024·2024-02-28
Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
Product
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1169-2024·2024-02-28
3M Surgical Blade Assembly Recalled for Burn Injury Risk During Use
3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.
Product
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1171-2024·2024-02-28
Cardiology imaging software may calculate heart chamber size incorrectly
Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.
Product
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2024·2024-02-28
ESG Cutting Forceps Jaw May Fracture During Use or Inspection
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
Product
ESG PK CUTTING FORCEPS, 5MM, 33CM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2024·2024-02-28
X-Ray C-Arm System Internal Board Defect Causes Abnormal Images
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
Product
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and proce
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1149-2024·2024-02-28
PERIFIX epidural kits recalled for incompatible filter straw connectors
B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.
Product
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1172-2024·2024-02-28
Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis
FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.
Product
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0961-2024·2024-02-21
GE Healthcare Incubators Bedside Panel Latch Failure Poses Fall Risk
GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.
Product
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0958-2024·2024-02-21
GE Healthcare Care Plus and Lullaby incubators recalled for bedside panel latching defect
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.
Product
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0957-2024·2024-02-21
GE Healthcare neonatal incubator bedside panels may fail to latch properly
GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.
Product
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0962-2024·2024-02-21
GE Healthcare Lullaby Incubator bedside panels may fail to latch properly
GE Healthcare Lullaby Incubator bedside panels and portholes may appear closed but not be properly latched. If impacted, these panels can disengage and fall open, creating a fall risk for patients.
Product
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0959-2024·2024-02-21
GE Healthcare Care Plus Incubator Hood Latching Defect Increases Fall Risk
GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.
Product
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0960-2024·2024-02-21
GE Healthcare incubator bedside panel may disengage and fall open
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
Product
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0980-2024·2024-02-21
Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
Product
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1078-2024·2024-02-21
Skin Graft Carrier Recalled for Manufacturing Ratio Defect
Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.
Product
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2024·2024-02-21
Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.
Product
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2024·2024-02-21
Portable X-ray system may move unexpectedly if improperly cleaned
The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.
Product
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2024·2024-02-21
Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use
Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.
Product
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2024·2024-02-21
global Medium embryo culture media recalled for potential development impairment
CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.
Product
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2024·2024-02-21
Bone Filler Tubes Recalled Due to Manufacturing Process Defect
The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.
Product
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1140-2024·2024-02-21
FilmArray GI diagnostic kits recalled due to false positive Norovirus results
BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.
Product
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
Category
Medical Device
Distribution
Distributed nationwide

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6076–6100 of 27364