State

Hawaii product recalls

20,324 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Hawaii consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

11976–12000 of 20324

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
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 (Drugs)·D-1082-2023·2023-08-16
Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity
Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
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-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-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-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-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-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