Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
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.
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.
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.
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.
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.
Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.
Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
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 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 UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.
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.
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.
Falcon Trading Co. is recalling SunRidge Farms Organic Chili Bean Blend due to potential contamination with the pesticides haloxyfop and thiamethoxam. Affected batches were distributed in seven U.S. states.
SunRidge Farms Organic Sunset Soup Mix is being recalled due to potential contamination with pesticides haloxyfop and thiamethoxam. Affected products were distributed to seven U.S. states.
Tops Markets LLC is recalling Christopher Ranch Peeled Garlic 6 oz. due to potential contamination with Clostridium botulinum from temperature abuse during storage. No illnesses have been reported.
XZL Jelly Snacks (12.68 oz bags, 100 cases) distributed to New York and Rhode Island are being recalled because they contain undeclared FD&C Yellow #5, Yellow #6, and Red #40 food coloring additives.
Silver Moon LP recalls 888 units of Burgundy Cherry Ice Cream for undeclared Red #40, Blue #1, and Blue #2 food dyes. Products were distributed under multiple labels in Northern California grocery stores and Loard's Ice Cream parlors.
Horizon Organic is recalling Chocolate Organic Lowfat Milk due to compromised package integrity. The affected products were distributed in Arizona, California, Nevada, and Oregon.
SunRidge Farms Organic Black Beans (Lot PND-23-11-36) are being recalled due to potential contamination with pesticides haloxyfop and thiamethoxam. The recall affects 1,092 sacks distributed across seven U.S. states.
Banana Ice Cream products sold in Northern California under four labels are being recalled due to undeclared Yellow #5 dye. The FDA-classified voluntary recall affects 664 units.
Loard's Ice Cream is recalling 1,076 units of Peppermint Ice Cream sold under four labels in Northern California because the product contains undeclared Red #40, which was not listed on the packaging.
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.
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.