State
72,913 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.
Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.
Which agencies issued them
These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico 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.
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
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.
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 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 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 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.
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.
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.
Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.
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.
Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.
Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
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.
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.
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.
CVS Lidocaine Wound Gel is being recalled because it failed pH specifications. The affected product is distributed nationwide.
Winnebago is recalling 2026-2027 Solis recreational vehicles because the liquid propane hose may be routed over the exhaust heat shield, posing a fire risk.
Shyft Group is recalling 2025 Utilimaster Velocity vehicles because the cargo carrying capacity label may list an incorrect load value, potentially leading to overloading.
Tesla is recalling certain vehicles running software version 2026.8.6 because the rearview camera image may be delayed when the vehicle is placed in reverse, breaching FMVSS 111.
Gulf States Toyota, Inc. is recalling certain 2026 Toyota 4Runner vehicles because the load carrying capacity label is incorrect. This error may lead to improper vehicle loading and increase the risk of a crash.
New Flyer is recalling 2022 XE40 transit buses because the speedometer may not illuminate when headlights are on, increasing crash risk.
Waymo is recalling 3,791 automated driving systems because software may allow vehicles to drive into standing water, increasing crash risk.