State
73,096 recalls have nationwide distribution and so reach California. 13,251 additional recalls listed California specifically in their distribution scope.
Of the 13,251 recalls naming California we have scored against our rubric, 1,605 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,846 (21%) are Severe.
Which agencies issued them
These figures cover only the 13,251 recalls whose distribution notice names California specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
BMW is recalling certain 2024 i7 M70 and related models because the integrated brake module may malfunction, potentially reducing braking power and vehicle control. Dealers will replace the module at no cost.
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.
Navistar is recalling 2024-2025 IC Bus school buses because brake caliper mounting bolts may not be properly tightened, allowing the brake caliper to detach and cause loss of braking ability. Owner notification was sent in November 2024.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Boston Scientific is recalling esophageal stent systems due to potential delivery catheter tip detachment during placement. Patients and providers with affected devices should contact the manufacturer for guidance.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.