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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2251–2275 of 13381

HighFDA (Devices)·Z-2636-2025·2025-10-01
Vasoview Hemopro 3 surgical system recalled for out-of-box mechanical failures
Maquet Cardiovascular is recalling the Vasoview Hemopro 3 endoscopic vessel harvesting system due to out-of-box mechanical failures including deformed jaws and heater wire defects discovered during the limited launch phase.
Product
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2025·2025-10-01
Philips surgical table motorized movement malfunction due to component deterioration
Philips Allura Xper FD10 operating room tables may experience motorized movement failure due to internal component deterioration. Manual positioning and imaging functions remain operational.
Product
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2598-2025·2025-10-01
Philips CT Exam Tables May Unexpectedly Descend During Patient Use
Philips Brilliance iCT CT systems may have faulty patient support tables that descend unexpectedly due to component misalignment, creating a risk of patient injury.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2603-2025·2025-10-01
Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips is recalling 3 Ingenuity CT Family Brazil scanner units due to a potential defect where the patient support table may descend unexpectedly to the lowest position after ball screw replacement. No injuries have been reported.
Product
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2619-2025·2025-10-01
Biomet Juggerknot Mini Soft Anchors recalled for product size mismatch
Cartons of Biomet Juggerknot Mini Soft Anchors labeled for 1.0mm products contain 1.4mm devices instead, creating a risk of incorrect surgical implantation.
Product
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2632-2025·2025-10-01
X-ray imaging system motorized positioning may fail due to component deterioration
Allura Xper FD20/10 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual operation and imaging remain functional.
Product
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2630-2025·2025-10-01
Philips Allura Xper FD20/20 X-Ray System: Motorized Movement Malfunction Risk
Philips is recalling 75 Allura Xper FD20/20 X-ray systems worldwide due to potential deterioration of internal components, which may disable motorized movements. Manual movements and imaging capabilities remain functional.
Product
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2623-2025·2025-10-01
Philips Allura Xper FD10 X-ray Systems Recalled for Component Deterioration
Philips is recalling the Allura Xper FD10 imaging system due to internal component deterioration that can disable motorized movements. Manual controls and X-ray imaging functionality remain available.
Product
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2025·2025-10-01
Philips X-ray Imaging System Motorized Functions May Fail Due to Component Deterioration
Philips Allura Xper FD20/15 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual controls and imaging functionality remain available.
Product
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2631-2025·2025-10-01
Philips Allura Xper FD20/20 Operating Room Table Motorized Movement Failure
Philips Allura Xper FD20/20 OR tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging functions remain available. FDA Class II recall affects 3 units outside the United States.
Product
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2635-2025·2025-10-01
Fluoroscopy System Component Deterioration May Disable Motorized Movements
Philips Allura CV20 fluoroscopy systems may lose motorized movement capability due to deterioration of internal components (battery, hard drive, power supply). Imaging and manual positioning remain available.
Product
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2620-2025·2025-10-01
Chromophare Surgical Light Systems recalled for powder coating stress and chipping
Stryker Communications is recalling Chromophare Surgical Light Systems due to stress lines in the powder coating that may cause chipping. 40 units were distributed nationwide.
Product
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2634-2025·2025-10-01
Philips OR Table motorized movements may fail due to component deterioration
Philips Allura Xper FD20/15 OR Tables may lose motorized movements due to deterioration of internal components including battery, hard drive, and power supply. Manual movements and imaging functionality remain available.
Product
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2483-2025·2025-09-24
3M Ranger Blood/Fluid Warming Sets recalled for clarification on operating parameters
3M Company recalled 530,470 units of Ranger Blood/Fluid Warming High Flow Sets worldwide due to unclear documentation about flow rates and temperature parameters. The field action aims to clarify outlet temperature location and inlet fluid temperatures.
Product
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2538-2025·2025-09-24
Wheelchair Power Assist Dial Recalled for Loss of Control Risk
Max Mobility Smart Drive MX2+ SpeedControl Dial is recalled for a faulty electrical connection that could cause loss of control, potentially resulting in injury. Approximately 25,389 units are affected.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2540-2025·2025-09-24
Wheelchair Power Assist Device Speed Control Dial Recalled for Loss of Control Risk
Max Mobility's Smart Drive MX2+ SpeedControl Dial has a faulty electrical connection that can cause loss of control of the wheelchair. The FDA has recalled 8,413 units distributed since April 2022.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2539-2025·2025-09-24
Wheelchair Power Assist Recalled for Potential Loss of Control Risk
Max Mobility is recalling the Smart Drive MX2+ SpeedControl Dial due to a faulty electrical connection that could cause loss of control. No injuries have been reported.
Product
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-2562-2025·2025-09-24
Exactech Equinoxe Reverse Shoulder Humeral Liners dimensional specification recall
Exactech Equinoxe Reverse Shoulder Humeral Liners are being recalled because the articular surface position is outside dimensional specifications in certain units distributed worldwide.
Product
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2564-2025·2025-09-24
Immunohistochemistry antibody recall due to weak staining risk
Agilent Technologies is recalling FLEX CD20cy antibodies used in immunohistochemistry because weak staining may cause false negative results in B-cell lymphoma identification.
Product
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2569-2025·2025-09-24
MEDITECH Expanse laboratory software data loss with simultaneous inputs
The MEDITECH Expanse Laboratory system may lose data from the first field when multiple keys are pressed simultaneously. Install the latest software update to resolve this issue.
Product
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2588-2025·2025-09-24
Heartstring III Proximal Seal System Recall Due to Device Failure Risks
Maquet Cardiovascular is recalling the Heartstring III Proximal Seal System (4.3 MM) due to three failure modes: failure to load, deploy, or provide adequate hemostasis. Healthcare providers should contact the manufacturer for guidance.
Product
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2581-2025·2025-09-24
Frontier Devices 16mm Distraction Pin Recall Due to Unvalidated Shelf Life
Folsom Metal Products is recalling 490 units of Frontier Devices 16mm Distraction Pins nationwide due to unvalidated shelf life labeling. The label claim has not been substantiated.
Product
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2565-2025·2025-09-24
Immunohistochemistry Antibody Recalled for Potential Weak Staining
Agilent Technologies is recalling certain lots of FLEX Monoclonal Mouse Anti-Human CD20cy antibodies because they may exhibit weak staining that could result in false negative CD20 identification.
Product
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2575-2025·2025-09-24
Hematology Analyzer May Produce Falsely Elevated Hemoglobin Results
Beckman Coulter's UniCel DxH 600 hematology analyzers may report falsely high hemoglobin levels in samples with elevated white blood cell counts, potentially leading to clinical misdiagnosis.
Product
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2583-2025·2025-09-24
Abbott i-STAT CG8+ Cartridges Recalled for Missing 510(k) Premarket Clearance
Abbott is recalling 8,962,450 i-STAT CG8+ diagnostic cartridges nationwide due to lack of FDA 510(k) premarket clearance for updated sample types and measurement parameters.
Product
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Category
Medical Device
Distribution
Distributed nationwide

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2251–2275 of 13381