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

2276–2300 of 13381

HighFDA (Devices)·Z-2560-2025·2025-09-24
VITROS Chemistry LAC Slides Calibration Failure Causes Test Delays
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides due to increased calibration failures that delay test results on clinical laboratory analyzer systems. Approximately 2,320 units are affected nationwide.
Product
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2591-2025·2025-09-24
Foley Catheter Trays With Incorrect Material Identification Labels
SureStep Foley catheter trays are being recalled because their inserts have incorrect material labels. Users may confuse latex with silicone or vice versa, which could cause allergic reactions or infections.
Product
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2587-2025·2025-09-24
Heartstring III Proximal Seal System Recalled for Loading and Deployment Failures
Maquet Cardiovascular is recalling 28,331 units of the Heartstring III Proximal Seal System for three failure modes: inability to load, failure to deploy, and inadequate hemostasis. The device is used during aortotomy procedures.
Product
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2025·2025-09-24
Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Dimensional Defect
Exactech is recalling Equinoxe Reverse Shoulder Humeral Liners due to articular surface positioning outside manufacturing specifications. Approximately 61,334 units distributed worldwide may be 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-2586-2025·2025-09-24
Heartstring III Proximal Seal System Recalls Due to Deployment and Hemostasis Failures
The FDA is recalling the Heartstring III Proximal Seal System due to failures in loading, deploying, or providing hemostasis during aortotomy closure. Affected devices may not properly seal, creating a risk of bleeding during cardiac surgery.
Product
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2574-2025·2025-09-24
Hematology Analyzer May Produce Erroneously High Hemoglobin Results
Beckman Coulter's UniCel DxH 800 hematology analyzer may produce incorrect hemoglobin measurements on samples with high white blood cell counts. Inaccurate results could lead to clinical misdiagnosis.
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-2558-2025·2025-09-24
Vercise Deep Brain Stimulation Systems Recall Due to Wire Breaks
Boston Scientific is recalling Vercise Deep Brain Stimulation Systems due to wire breaks in implanted pulse generators that prevent therapy. Device removal and replacement is typically required.
Product
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2589-2025·2025-09-24
Foley Catheter Tray System Recalls Due to Incorrect Material Inserts
SureStep Foley Tray System units contain incorrect inserts labeled incorrectly, risking patient allergic reactions and infections if the wrong material type is used.
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-2590-2025·2025-09-24
Foley Catheter Tray System Recalled Due to Incorrect Component Materials
C.R. Bard is recalling 4,300 SureStep Foley Tray System units with incorrect catheter inserts that may mislead users about material type and antimicrobial coating, risking allergic reactions and infections.
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-2570-2025·2025-09-24
Pinnacle Radiation Therapy Planning System software ROI calculation error recall
Pinnacle Radiation Therapy Planning System software contains a defect causing potential Region of Interest calculation errors in specific patient positioning modes. Philips is recalling 810 affected units for software correction.
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
HighFDA (Devices)·Z-2572-2025·2025-09-24
Hematology Analyzer May Report Falsely High Hemoglobin Levels
Beckman Coulter hematology analyzers may report erroneously high hemoglobin results in samples with elevated white blood cell counts, potentially affecting patient diagnoses.
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-2573-2025·2025-09-24
Hematology Analyzers May Produce Erroneously High Hemoglobin Results
The UniCel DxH 690T hematology analyzer may produce erroneously high hemoglobin results when testing samples with elevated white blood cell counts. Incorrect readings could affect patient diagnosis and treatment decisions.
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-2579-2025·2025-09-24
Distraction Pin Recall Due to Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling 14 mm Distraction Pins with unvalidated shelf life labeling. The recall affects approximately 10,960 units distributed nationwide.
Product
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2582-2025·2025-09-24
i-STAT CG4+ Cartridge Recalled for Missing FDA Premarket Clearance
Abbott is recalling approximately 9 million i-STAT CG4+ cartridges nationwide because they were marketed without FDA 510(k) premarket clearance for updated lactate sample type and pH/PO2 measurement specifications.
Product
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2025·2025-09-24
Immunohistochemistry Antibody Recalled for Weak Staining and Diagnostic Error Risk
Agilent is recalling FLEX Monoclonal Anti-Human CD20cy antibody due to weak staining that may result in false negative B-cell identification. About 4,145 units were distributed nationwide.
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-2571-2025·2025-09-24
Handheld UV-C Germicidal Wand Recalled for Unsafe Radiation Emission Levels
BigTree Sales Inc. is recalling its handheld UV-C germicidal wand (SKU BT-GERMWAND-LRG-WHT) because it emits unsafe levels of ultraviolet-C radiation that can reach high-risk exposure thresholds in approximately 2.2 minutes, creating a risk of 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
ModerateFDA (Devices)·Z-2580-2025·2025-09-24
Frontier Devices Distraction Pins Recalled for Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling Frontier Devices 14 mm Distraction Pins because the labeled shelf life has not been validated. The recall affects products distributed nationwide from August 2020 through July 2025.
Product
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2559-2025·2025-09-24
VITROS Chemistry LAC Slides Affected by Increased Calibration Failures
Certain VITROS Chemistry LAC Slides are failing to calibrate properly, delaying test results. Affected lots are from coating 0130 and above with expiration dates through January 2027.
Product
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2576-2025·2025-09-24
Frontier Devices 12 mm Distraction Pins Recalled for Unvalidated Shelf Life
Folsom Metal Products is recalling 3790 units of Frontier Devices 12 mm Distraction Pins due to unvalidated shelf life labeling. Users should contact their healthcare provider for guidance.
Product
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2578-2025·2025-09-24
Frontier Devices 14 mm Distraction Pin Recall: Unvalidated Shelf Life Labeling
Folsom Metal Products recalled 2,700 units of Frontier Devices distraction pins due to labeling that includes shelf life that has not been validated. The recall affects devices distributed nationwide from August 2020 to July 2025.
Product
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2584-2025·2025-09-24
i-STAT EG7+ Cartridge Recalled for Lack of Premarket Clearance
Abbott Point Of Care is recalling i-STAT EG7+ cartridges nationwide because the updated sample types and measurement ranges for potassium, ionized calcium, pH, and PO2 were not cleared through the FDA's 510(k) premarket review process.
Product
i-STAT EG7+ cartridge. List Number: 03P76-25.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2585-2025·2025-09-24
i-STAT Cartridges Recalled for Lack of FDA Premarket Clearance
Abbott Point Of Care is recalling approximately 547,250 i-STAT cartridges nationwide because they lack FDA 510(k) premarket clearance for updated specifications, including revised sample types and measurement ranges.
Product
i-STAT EG6+ cartridge. List Number: 03P77-25.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2577-2025·2025-09-24
Frontier Devices 12 mm Distraction Pins Recalled for Unvalidated Shelf Life Labeling
Folsom Metal Products is recalling Frontier Devices 12 mm Distraction Pins due to labeling that includes unvalidated shelf life. The recall affects 160 units distributed nationwide from August 2020 through July 2025.
Product
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2484-2025·2025-09-17
ViziShot 2FLEX Aspiration Needle Recalled for Potential Deformed Tips
Olympus Corporation of the Americas is recalling ViziShot 2FLEX Single Use Aspiration Needles (Model NA-U403SX-4019) due to potential deformation of needle tips. The defect may cause unintended tissue trauma during biopsy procedures.
Product
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2549-2025·2025-09-17
Shoulder Surgical Device Recalled Due to Potential Reamer Binding
Encore Medical is recalling the DJO SURGICAL FA S Altivate Reverse Glenoid Tray shoulder replacement device. The surgical reamer may kick or bind during use.
Product
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for u
Category
Medical Device
Distribution
Distributed nationwide

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