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

9351–9375 of 39932

HighFDA (Devices)·Z-2361-2023·2023-08-16
Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors
Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.
Product
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2360-2023·2023-08-16
Angiography systems recalled due to thermal overload in cable connectors
Siemens ARTIS icono floor angiography systems may experience thermal overload in cable connectors during fluoroscopy, causing burning smell and loss of imaging capability. The recall affects 7 units worldwide.
Product
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2394-2023·2023-08-16
HoverMatt air transfer mattress contains undersized unit, increases injury risk
Stryker's HoverMatt 39-inch inflatable transfer mattresses contain 34-inch units inside, reducing available support surface. This increases friction during patient transfers and raises the risk of skin tears.
Product
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2354-2023·2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty
Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2023·2023-08-16
Olympus Endoscope Reprocessor Labeling Revised for Compatibility and Sterilization Parameters
Olympus is revising labeling for its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors due to incompatible endoscope models and incorrect sterilization parameters in previous labeling. The revisions remove two endoscope models from the compatibility list and correct gas sterilization concentration requirements.
Product
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2355-2023·2023-08-16
LINK MP Hip Stem Trial Instruments difficult to remove after implantation
The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2023·2023-08-16
Hip implant trial stem: increased removal force may extend surgery
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2358-2023·2023-08-16
FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.
Product
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2023·2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force
LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2023·2023-08-16
Hip Stem Trial Implant May Require Excessive Force During Removal
A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2023·2023-08-16
Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk
Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2362-2023·2023-08-16
Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk
FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.
Product
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2395-2023·2023-08-16
MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling
Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.
Product
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2023·2023-08-16
LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal
Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2340-2023·2023-08-16
Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision
Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.
Product
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2353-2023·2023-08-16
LINK MP Hip Stem Difficult to Remove After Surgical Implantation
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2400-2023·2023-08-16
MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect
Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2349-2023·2023-08-16
Hip Stem Trial Instrument Difficult to Remove After Impaction
LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2363-2023·2023-08-16
Surgical Spinal Tap Device Recalled for Incorrect Laser Marking
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2399-2023·2023-08-16
MRI System Cable Installation Issue During Service Setup
Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2398-2023·2023-08-16
Philips Ingenia Elition X MR Systems Diagnostic Cable Installation Issue
Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.
Product
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2343-2023·2023-08-16
Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility
Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.
Product
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2392-2023·2023-08-16
Canon Medical INFX-8000C Tableside Console PWB Requires Replacement
Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.
Product
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2365-2023·2023-08-16
Medtronic InterStim Ground Pad Recalled for Incorrect Expiration Date Label
Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.
Product
Medtronic InterStim Ground Pad REF 041826
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2281-2023·2023-08-09
Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Category
Medical Device
Distribution
Distributed nationwide

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