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

5701–5725 of 39968

HighFDA (Devices)·Z-0054-2025·2024-10-16
MEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
Integra LifeSciences recalls MEDIHONEY Dressing applicator pouches due to potential pinholes that may compromise sterility. The recall affects approximately 120,124 units distributed across 36 US states and internationally.
Product
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2025·2024-10-16
FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode
Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Category
Medical Device
Distribution
25 states
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-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-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-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
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-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-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-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
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-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-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-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-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-3311-2024·2024-10-09
Contact lenses with misaligned axis may cause poor visual acuity
CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.
Product
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3309-2024·2024-10-09
Stryker Tornier Shoulder Implant Insert May Not Seat Securely
Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
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-3310-2024·2024-10-09
BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect
CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.
Product
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0009-2025·2024-10-09
BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes
The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.
Product
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0019-2025·2024-10-09
Hemodialysis console blood leak sensor may fail to trigger alarm
A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.
Product
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0006-2025·2024-10-09
Miami J Select Collar Recalled Due to Adhesive Failure
Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.
Product
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Category
Medical Device
Distribution
39 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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5701–5725 of 39968