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

7276–7300 of 40007

HighFDA (Devices)·Z-1825-2024·2024-05-22
Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit Recall Due to CSF Leakage Risk
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.
Product
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Cat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1829-2024·2024-05-22
MRI System Software May Fail to Warn of Inadequate Ventilation
Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.
Product
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2024·2024-05-15
Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events
Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.
Product
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Mark
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1609-2024·2024-05-15
Insulin pump app may crash and drain battery, risking insulin delivery interruption
Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1730-2024·2024-05-15
Vyaire Twin Tube Sample Line Nozzle Separation Recall
Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.
Product
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1776-2024·2024-05-15
Stealth S8 neurosurgical navigation software display error affecting surgical guidance
Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.
Product
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1777-2024·2024-05-15
GE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly
GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.
Product
GE Healthcare Innova IGS 5, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2024·2024-05-15
GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard
GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.
Product
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1766-2024·2024-05-15
Medical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings
Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.
Product
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1762-2024·2024-05-15
Hemodialysis Vascular Access Kit Recalled for Loose Metal Shavings
Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.
Product
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1763-2024·2024-05-15
Duraflow 2 vascular catheter kit recalled for loose metal shavings
Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, potentially requiring surgical removal.
Product
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1781-2024·2024-05-15
GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.
Product
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1759-2024·2024-05-15
Randox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.
Product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1778-2024·2024-05-15
GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall
GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.
Product
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1775-2024·2024-05-15
Baxter Spectrum IQ Infusion Pump recalled due to improper pre-release testing
Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.
Product
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2024·2024-05-15
Interact Discovery RT X-ray Systems Recalled for Component Fall Risk
GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.
Product
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1767-2024·2024-05-15
FDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk
Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially requiring surgical removal.
Product
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1765-2024·2024-05-15
Vascular Access Catheter Recall Due to Metal Shaving Risk
Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
Product
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1758-2024·2024-05-15
Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues
SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.
Product
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1773-2024·2024-05-15
Vascular catheter recalled for potential metal shavings that may cause embolization
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
Product
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1764-2024·2024-05-15
DURAFLOW 2 Vascular Access Device Recalled for Loose Metal Shavings
Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.
Product
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1772-2024·2024-05-15
Angiodynamics vascular access catheter subject to voluntary recall
Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.
Product
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1761-2024·2024-05-15
Vascular access device recalled due to loose metal shavings
DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.
Product
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1769-2024·2024-05-15
Angiodynamics Duramax Vascular Access Kit Recall Due to Metal Shavings
Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
Product
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1784-2024·2024-05-15
X-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion
NRT X-RAY A/S recalls Intelli-C X-ray tabletops due to faulty firmware and worn motor components that may cause uncontrolled C-arm motion, potentially striking patients or operators.
Product
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Category
Medical Device
Distribution
Distributed nationwide

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7276–7300 of 40007