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

6451–6475 of 27364

HighFDA (Devices)·Z-0706-2024·2024-01-17
XScribe Cardiac Stress Testing System may distort ECG readings
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
Product
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0640-2024·2024-01-17
Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis
Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.
Product
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0660-2024·2024-01-17
Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
Product
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0648-2024·2024-01-17
Abiomed Oscor Introducer Kit sterile barrier holes risk infection
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
Product
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0698-2024·2024-01-17
Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
Product
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2024·2024-01-17
Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Product
BrightView, Gamma Camera System, Product Code 882480.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2024·2024-01-17
VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
Product
VADER pedicle system, torque wrench, Catalog Number 42-703
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0672-2024·2024-01-17
SPRYSTEP VECTOR KAFO ankle-foot orthosis recalled for structural failure risk
The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.
Product
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0673-2024·2024-01-17
Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates
Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.
Product
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0646-2024·2024-01-17
Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
Product
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0647-2024·2024-01-17
Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Product
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0654-2024·2024-01-17
Abiomed Introducer Kits recalled due to sterile barrier compromise
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
Product
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2024·2024-01-17
Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
Product
BrightView X, Gamma Camera, Product Code 882478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2024·2024-01-17
Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws
Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2024·2024-01-17
Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.
Product
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0645-2024·2024-01-17
Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0681-2024·2024-01-17
Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent
Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.
Product
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
Category
Medical Device
Distribution
48 states
SevereFDA (Devices)·Z-0591-2024·2024-01-10
Omnipod 5 insulin pump app bolus calculator decimal point error
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
Product
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2024·2024-01-10
Tracheostomy care sets recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
Product
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0596-2024·2024-01-10
Regard Dressing Change Kit Recalled Due to Defective Irrigation Solution
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
Product
Regard Dressing change kit, Item Number 800026006
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0592-2024·2024-01-10
Tracheostomy care kits recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Product
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0593-2024·2024-01-10
Dressing change tray recalled for sterility assurance failure
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Product
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2024·2024-01-10
FDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
Product
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2024·2024-01-10
Spinal fixation screws recalled due to incorrect size laser marking
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
Product
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0631-2024·2024-01-10
Covidien Valleylab FT10 Energy Platform software issue causes inoperability
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Product
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Category
Medical Device
Distribution
Distributed nationwide

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6451–6475 of 27364