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 27393

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-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-2393-2023·2023-08-16
Ellacor System recalled for bearing adhesive defect risk
The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.
Product
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
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-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-2359-2023·2023-08-16
Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect
Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.
Product
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2023·2023-08-16
Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass
Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2350-2023·2023-08-16
Hip stem trial instruments recalled due to excessive removal force
LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2396-2023·2023-08-16
Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass
Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
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-2342-2023·2023-08-16
Olympus OER-Pro Endoscope Reprocessor Revised Labeling for Equipment Compatibility
Olympus revised OER-Pro labeling because two endoscope models (LF-V, LF-P) are no longer compatible. Sterilization parameters and cleaning procedures have also changed.
Product
Olympus Endoscope Reprocessor OER-Pro-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-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-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
HighFDA (Devices)·Z-2341-2023·2023-08-16
Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update
Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.
Product
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
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-2364-2023·2023-08-16
Medical Device Recall: UroLift Visual Obturator Weld Defect Risk
The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.
Product
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2023·2023-08-16
LINK MP Hip Stem trial instruments may require increased removal force during surgery
LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2357-2023·2023-08-16
VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.
Product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2366-2023·2023-08-16
Medline Total Hip Kit Recalled for Expired Prep Solution
Medline is recalling the Total Hip Kit (REF DYNJ903275S) because the included prep solution expires before the kit itself expires. Sixteen kits with lot code 23CDC733 were distributed nationwide.
Product
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
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-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
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
HighFDA (Devices)·Z-2311-2023·2023-08-09
Procedural Kits Containing Ultrasound Gel Recalled for Sterility Concerns
Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2023·2023-08-09
NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.
Product
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2023·2023-08-09
SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays
Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Mode
Category
Medical Device
Distribution
Distributed nationwide

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7276–7300 of 27393