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

5026–5050 of 27375

SevereFDA (Devices)·Z-2163-2024·2024-07-03
Philips SENSE XL TORSO COIL Recall Due to Potential Patient Burn Hazard
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
Product
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2165-2024·2024-07-03
Philips SENSE XL Torso Coil 1.5T Recalled for Overheating Risk
Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.
Product
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2024·2024-07-03
Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects
Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.
Product
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2024·2024-07-03
Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose
Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.
Product
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2024·2024-07-03
Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction
Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.
Product
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2024·2024-07-03
GE CARESCAPE Monitors May Fail to Power On After Battery Replacement
GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.
Product
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2217-2024·2024-07-03
NovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk
NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.
Product
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2024·2024-07-03
Prelude Roadster Guide Sheaths Recalled Due to Instruction Defect
Merit Medical Systems is recalling Prelude Roadster Guide Sheaths due to an instructional defect. Older instructions directing tight connection assembly may cause over-tightening, leading to swivel nut detachment.
Product
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2212-2024·2024-07-03
Medtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect
Medtronic is recalling 82 implantable cardioverter defibrillators due to a manufacturing defect involving weld cracks discovered during quality control testing before distribution to patients.
Product
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2173-2024·2024-07-03
Sight OLO CBC Test Kit Lot Recalled for Bacterial Contamination
One lot of Sight OLO CBC Test Kit is being recalled due to bacterial contamination that causes artificially elevated platelet counts. The affected kits may produce inaccurate test results.
Product
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2024·2024-07-03
NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk
FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.
Product
NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2190-2024·2024-07-03
Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.
Product
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2024·2024-07-03
X-ray Table Touch Display Power Supply Fire Hazard
Siemens is recalling AXIOM MULTIX MT X-ray patient tables due to a potential short circuit in the Touch Display power supply that may cause overheating and fire. Fifty units were distributed nationwide.
Product
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2024·2024-07-03
Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect
Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.
Product
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2024·2024-07-03
X-ray table recalled for fire hazard from power supply unit short circuit
Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.
Product
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2024·2024-07-03
Implantable Cardioverter Defibrillator with Weld Crack Defect Recalled
Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.
Product
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2024·2024-07-03
Patient Monitors May Fail to Display Vitals After Power Loss
GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2169-2024·2024-07-03
GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss
GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2204-2024·2024-07-03
Medtronic Implantable Cardioverter Defibrillator Recalled Due to Weld Crack Defect
Medtronic is recalling 6 units of the MIRRO MRI VR SureScan implantable cardioverter defibrillator due to a potential manufacturing defect. The devices failed manufacturing quality checks because of a weld crack.
Product
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2208-2024·2024-07-03
Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect
Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.
Product
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2186-2024·2024-07-03
Siemens Multix TOP X-ray Table Recalled Due to Fire Risk
Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.
Product
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2207-2024·2024-07-03
Medtronic COBALT DR MRI SureScan ICD Recalled Due to Manufacturing Weld Crack
Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.
Product
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2185-2024·2024-07-03
AXIOM Vertix Solitaire Medical Imaging Device Recall: Fire Risk from Power Supply Defect
Siemens is recalling 4 AXIOM Vertix Solitaire medical imaging devices due to a short circuit in the touch display power supply that may cause overheating and fire. Units with serial numbers 1004, 1006, 1011, and 1014 are affected.
Product
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2195-2024·2024-07-03
Medtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.
Product
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2024·2024-07-03
Medtronic COBALT XT Heart Devices Recalled Due to Manufacturing Defect
Medtronic is recalling 58 COBALT XT HF QUAD implantable cardioverter defibrillators worldwide due to a weld crack manufacturing defect that caused devices to fail quality checks.
Product
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide

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5026–5050 of 27375