State
73,092 recalls have nationwide distribution and so reach Rhode Island. 3,046 additional recalls listed Rhode Island specifically in their distribution scope.
Of the 3,046 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 3,046 recalls whose distribution notice names Rhode Island specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.
Merit Medical Systems is recalling 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and infection.
Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.
Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular imaging procedures.
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.
Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.
Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.