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

7926–7950 of 40007

HighFDA (Devices)·Z-1178-2024·2024-02-28
Azurion 7 Medical Imaging System May Lose Power During Procedures
Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.
Product
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
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-1179-2024·2024-02-28
Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement
W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.
Product
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2024·2024-02-28
Philips Azurion Interventional X-ray Systems framegrabber card may fail to display images
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223;
Category
Medical Device
Distribution
Distributed nationwide
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-1144-2024·2024-02-28
Philips Allura Xper Interventional X-ray System Display and Imaging Malfunction
A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2024·2024-02-28
EndoVive Replacement Button Kits mislabeled with incorrect sizing
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Category
Medical Device
Distribution
0 states
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-1175-2024·2024-02-28
Automated Impella Controller Software Update Resolves Pump Recognition Issue
Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.
Product
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
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-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
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
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
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-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-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-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-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
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
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
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-1141-2024·2024-02-21
HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw
HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.
Product
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2024·2024-02-21
Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images
Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.
Product
CombiDiagnost R90 1.1 (709031)
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

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7926–7950 of 40007