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

2176–2200 of 27375

HighFDA (Devices)·Z-2628-2025·2025-10-01
Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2025·2025-10-01
Philips Brilliance iCT SP CT Systems Patient Support Table Descent
Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2025·2025-10-01
MyDay toric contact lenses recalled after one lot used invalid sterilization
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2540-2025·2025-09-24
SmartDrive speed control dials recalled over faulty motor electrical connection
SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCMC, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 8,413 units are affected.
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
CriticalFDA (Devices)·Z-2483-2025·2025-09-24
Blood and fluid warming sets recalled to clarify flow rates and temperatures
3M Ranger Blood/Fluid Warming High Flow Sets are the subject of a field action to clarify flow rates, inlet fluid temperatures and the location of the outlet temperature. The FDA classified it as Class I.
Product
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2539-2025·2025-09-24
SmartDrive MX2-3DCK dials recalled over faulty connection to wheelchair motor
SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.
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
CriticalFDA (Devices)·Z-2538-2025·2025-09-24
Wheelchair power assist speed dials recalled over potential loss of control
SmartDrive MX2+ SpeedControl Dials are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. The FDA classified the action as Class I. 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
HighFDA (Devices)·Z-2587-2025·2025-09-24
Heartstring III 3.8 mm seal systems recalled over three identified failure modes
Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.
Product
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2571-2025·2025-09-24
Germicidal wands recalled because they emit unsafe levels of UVC radiation
A handheld ultraviolet-C germicidal wand is recalled because it emits an unsafe level of UVC radiation, reaching the Risk Group 3 exposure limit in about 2.2 minutes and risking skin and eye injuries.
Product
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2590-2025·2025-09-24
Foley catheter trays recalled because inserts describe the wrong catheter material
SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
Product
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2025·2025-09-24
Shoulder humeral liners recalled over articular surface outside dimensional specification
Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.
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-2589-2025·2025-09-24
Bardex Foley catheter trays recalled over inserts describing the wrong material
SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.
Product
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2025·2025-09-24
CD20 antibody reagent recalled over weak staining causing false negative results
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.
Product
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 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-2564-2025·2025-09-24
CD20 reagent lots recalled over weak staining risking false negative identification
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.
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-2565-2025·2025-09-24
CD20 antibody lots recalled over weak staining risking false negative results
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
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
DxH 600 hematology analyzers recalled over erroneously high hemoglobin results
UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
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-2588-2025·2025-09-24
Heartstring III 4.3 mm seal systems recalled over loading and deployment failures
Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.
Product
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2025·2025-09-24
Reverse shoulder liners recalled over articular surface outside dimensional specification
Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.
Product
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2573-2025·2025-09-24
Hematology analyzers recalled over erroneously high hemoglobin results in some samples
UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Product
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2591-2025·2025-09-24
Lubri-Sil Foley trays recalled over inserts describing the wrong catheter material
SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.
Product
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2025·2025-09-24
Deep brain stimulation implant manuals recalled after wire breaks in generators
The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.
Product
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2572-2025·2025-09-24
DxH 900 hematology analyzers recalled over erroneously high hemoglobin results
UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Product
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2025·2025-09-24
Heartstring III seal systems recalled over failures to load, deploy and seal
Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.
Product
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2574-2025·2025-09-24
DxH 800 hematology analyzers recalled over erroneously high hemoglobin results
UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
Product
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2570-2025·2025-09-24
Radiation planning software recalled over image errors in three patient orientations
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
Product
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
Category
Medical Device
Distribution
Distributed nationwide

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2176–2200 of 27375