State
72,913 recalls have nationwide distribution and so reach Rhode Island. 3,043 additional recalls listed Rhode Island specifically in their distribution scope.
Of the 3,043 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 570 (19%) are Severe.
Which agencies issued them
These figures cover only the 3,043 recalls whose distribution notice names Rhode Island specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.
Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
Calypso Tropic Tango Lemonade is being recalled because it contains undeclared Yellow No. 5. The action covers 299,779 cases distributed nationwide and to four other markets.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.
Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.