State
72,913 recalls have nationwide distribution and so reach California. 13,245 additional recalls listed California specifically in their distribution scope.
Of the 13,245 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 2,843 (21%) are Severe.
Which agencies issued them
These figures cover only the 13,245 recalls whose distribution notice names California specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.
Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.
Peppermint Ice Cream sold under four store labels is being recalled because it contains undeclared Red #40. 1,076 units are affected.
Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Burgundy Cherry Ice Cream sold under four store labels is being recalled because it contains undeclared Red #40, Blue #1 and Blue #2. 888 units are affected.
SunRidge Farms Organic Sunset Soup Mix in 25 lb cases is being recalled over potential contamination with the pesticides haloxyfop and thiamethoxam.
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.
Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.
Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.
Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.
Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.
Banana Ice Cream sold under four store labels is being recalled because it contains undeclared Yellow #5. 664 units are affected.