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.
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.
Medline Industries is recalling three models of surgical convenience kits—Lithotomy Packs and Lap Basin—due to calibration issues with sterilization equipment that could affect the sterility assurance 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.
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.
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, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.
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.
Banana Ice Cream sold under four store labels is being recalled because it contains undeclared Yellow #5. 664 units are affected.
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.
Horizon Organic Chocolate Organic Lowfat Milk boxes are being recalled because package integrity was compromised. 3,522 cases are affected.
Falcon Trading Co., Inc. is recalling SunRidge Farms Organic Black Beans due to potential contamination with the pesticides haloxyfop and thiamethoxam.
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.
Garland Fresh Peeled Garlic in 6 oz bags is being recalled over potential contamination with Clostridium botulinum, due to a risk of temperature abuse during chilled storage.
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
Medline Industries is recalling five models of urology convenience kits due to calibration issues in sterilization and packaging equipment that may compromise sterility assurance.
Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.
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.
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.
Katalyst Surgical is correcting instructions for DEX Ophthalmic Tissue Forceps (Model DVF4022-25-S) due to a field safety issue related to the Instructions for Use (IFU).
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.
Nova Bus is recalling certain LFS transit buses because the driver's speaker hole door may lack the prime glazing manufacturer DOT code mark, breaching FMVSS 205.
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
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.
KLG Kesar Mukhwas is being recalled because it contains undeclared food colorings Yellow 6, Blue 1 and Yellow 5, along with unapproved Acid Red 14. 347 pouches are affected.