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

7051–7075 of 13512

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-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-1177-2024·2024-02-28
Azurion 5 X-Ray System Generator May Fail Due to Circuit Short
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
Product
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1142-2024·2024-02-28
Dental cement capsules recalled due to manufacturing defect affecting curing
IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.
Product
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1168-2024·2024-02-28
W&H Surgical Handpiece S-12 Recalled for Incorrect Laser Marking
W&H Surgical handpiece S-12 devices were incorrectly laser marked with '1:1' instead of the correct '1:2' during production. 160 units are affected.
Product
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1180-2024·2024-02-28
Medline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling
Medline is recalling 1.3 million units of bleach germicidal wipes due to stability concerns. Products labeled for 24-month shelf life are only safe and effective for 12 months.
Product
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC35141
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-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-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-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-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-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-1072-2024·2024-02-21
Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues
Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.
Product
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
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-1139-2024·2024-02-21
BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results
BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2024·2024-02-21
Philips Recalls ProxiDiagnost Radiography Systems for Patient Data Display and Security Issues
Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.
Product
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
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
0 states
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-1076-2024·2024-02-21
FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect
Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.
Product
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
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-1068-2024·2024-02-21
OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility
OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.
Product
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1075-2024·2024-02-21
Medical Device Control Panel Contaminated with Norovirus, Causes False Positive Results
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.
Product
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2024·2024-02-21
Captus 4000e Thyroid Uptake Systems spring failure poses fall risk
Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.
Product
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1056-2024·2024-02-21
Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk
NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.
Product
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Category
Medical Device
Distribution
Distributed nationwide

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7051–7075 of 13512