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

7176–7200 of 13652

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-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-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-1170-2024·2024-02-28
3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
Product
3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
Category
Medical Device
Distribution
0 states
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-1152-2024·2024-02-28
Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1148-2024·2024-02-28
Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment
Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.
Product
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
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
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-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-1173-2024·2024-02-28
OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.
Product
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1174-2024·2024-02-28
Aquabiliti saline flush syringes recalled for potential sodium chloride content deficiency
MRP, LLC is recalling AQUABILITI AQUASTAT saline flush syringes because they may fail to meet USP standards for sodium chloride content after 12 months.
Product
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
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-1156-2024·2024-02-28
Philips Allura Xper X-ray System Memory Modules May Stop Functioning
Philips Allura Xper fluoroscopic X-ray systems may experience memory module failures that cause the system to stop functioning and prevent imaging. This malfunction could delay critical medical procedures.
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1146-2024·2024-02-28
Henry Schein Criterion Level 3 Earloop Masks Recalled for Non-Validated Equipment
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
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-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
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-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-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-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

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7176–7200 of 13652