State

Rhode Island product recalls

73,190 recalls have nationwide distribution and so reach Rhode Island. 3,047 additional recalls listed Rhode Island specifically in their distribution scope.

What the numbers show

Total: 3,047
Critical: 221
Severe: 572
Most recent: 2026-09-30

Of the 3,047 recalls naming Rhode Island we have scored against our rubric, 221 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 572 (19%) are Severe.

Which agencies issued them

These figures cover only the 3,047 recalls whose distribution notice names Rhode Island specifically. The 73,190 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13926–13950 of 76237

HighFDA (Devices)·Z-0332-2024·2023-11-29
Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process
Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.
Product
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0397-2024·2023-11-29
EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.
Product
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2024·2023-11-29
Surgical Anchor Plug Devices Recalled for Potential Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend surgery time.
Product
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0328-2024·2023-11-29
Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation
Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.
Product
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2024·2023-11-29
BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP
BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.
Product
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2024·2023-11-29
Curaplex Manual Resuscitators Recalled for Potential CO2 Rebreathing Risk
SunMed Holdings is recalling Curaplex manual resuscitators with integrated manometers due to a backwards leak in the patient valve that allows carbon dioxide rebreathing. All units manufactured from September 2018 to present and distributed nationwide are affected.
Product
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2024·2023-11-29
Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.
Product
Achieva 1.5T Initial System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2024·2023-11-29
Alinity c Iron Reagent Recalled for Falsely Elevated Test Results
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
Product
Alinity c Iron Reagent, Reference Number 08P3920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0338-2024·2023-11-29
Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying
Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.
Product
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2024·2023-11-29
Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.
Product
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2024·2023-11-29
Transnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process
Aizu Olympus is recalling the Transnasal Esophagovideoscope (Model PEF-V) because the channel air drying process was not validated, resulting in some units with wet channels that could cause infection.
Product
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2024·2023-11-29
Surgical implant anchor plugs may contain metal burrs affecting insertion
Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.
Product
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0384-2024·2023-11-29
Compress Device Short Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.
Product
Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2024·2023-11-29
IRON assay kits recalled for inaccurate diagnostic results
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0362-2024·2023-11-29
BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak
SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.
Product
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2024·2023-11-29
Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.
Product
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2024·2023-11-29
Biomet Compress Device Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.
Product
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2024·2023-11-29
Gastroscope Devices Recalled for Inadequate Channel Drying Process
Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.
Product
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0399-2024·2023-11-29
ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2024·2023-11-29
Robotic patient positioning system may move unexpectedly after interruption
The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0113-2024·2023-11-29
Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0337-2024·2023-11-29
Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk
Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.
Product
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0377-2024·2023-11-29
Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
Product
Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2024·2023-11-29
Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled
Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Category
Medical Device
Distribution
Distributed nationwide