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

4826–4850 of 13449

HighFDA (Devices)·Z-0035-2025·2024-10-16
Philips Patient Information Center iX Network Connectivity Issue Affects Settings Synchronization
Philips Patient Information Center iX devices may fail to synchronize settings when network DHCP leases expire during offline operation, causing the devices to receive new IP addresses that are not recognized after reconnection.
Product
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2025·2024-10-16
Tonsil tray kits recalled for containing component under improper use recall
Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.
Product
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2025·2024-10-16
Endoscopy and Bronchoscopy Systems Power Cord Defect Risk
Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.
Product
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2025·2024-10-16
Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.
Product
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2025·2024-10-16
BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results
BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.
Product
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0037-2025·2024-10-16
FDA Recalls EPIONE Device Due to Internal Component Corrosion
Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.
Product
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. Du
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0041-2025·2024-10-16
Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch
Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.
Product
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2025·2024-10-16
Aligned Medical T and A Pack Recalled for Component Misuse Risk
Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.
Product
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0024-2025·2024-10-16
iCast Covered Stent Recalled for Unique Device Identifier Labeling Error
Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0029-2025·2024-10-16
Aligned Medical Septo Pack recalled for containing component under FDA recall
The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.
Product
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0040-2025·2024-10-16
Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch
FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.
Product
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0044-2025·2024-10-16
MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error
Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.
Product
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0031-2025·2024-10-16
Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component
Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.
Product
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0028-2025·2024-10-16
Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
Product
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3208-2024·2024-10-09
Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency
Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.
Product
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0003-2025·2024-10-09
MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact
Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.
Product
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
Category
Medical Device
Distribution
53 states
SevereFDA (Devices)·Z-0002-2025·2024-10-09
MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact
MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.
Product
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809,
Category
Medical Device
Distribution
53 states
SevereFDA (Devices)·Z-3207-2024·2024-10-09
Percussionaire IPV In-Line Valve Recall: Blue Cap Removal Labeling Update
Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.
Product
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2025·2024-10-09
Neo-Tee T-Piece Resuscitator circuit flow controller may come apart
Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.
Product
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0001-2025·2024-10-09
MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk
Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.
Product
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-3303-2024·2024-10-09
Urinalysis reagent strips recalled for reduced protein detection sensitivity
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
Product
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0008-2025·2024-10-09
Dental Ultrasonic Cleaner Recalled for Bacterial Contamination
Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.
Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-3304-2024·2024-10-09
ADVIA Centaur aTPO Assay kits recalled due to positive result bias
Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.
Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3313-2024·2024-10-09
Alcon contact lenses recalled for manufacturing quality defect
Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.
Product
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0007-2025·2024-10-09
Philips IntelliVue G7m Anesthesia Gas Module Pump Failure
Philips IntelliVue G7m Anesthesia Gas Modules may have a faulty sample gas pump that could stop working, interrupting gas measurement. Affected devices have serial numbers DE43800129 through DE43812627.
Product
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Category
Medical Device
Distribution
Distributed nationwide

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4826–4850 of 13449