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.
Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.
Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.
GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.
GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.
Tesla is recalling certain 2025 and 2026 Model Y vehicles because the certification label may not have been installed. Missing weight information on the label could lead to vehicle overloading and increase crash risk.
Amazon is recalling Amazon Basics 55 Lbs. Adjustable Dumbbells because weight plates can fail to engage completely and dislodge during use, posing an impact hazard. No injuries have been reported.
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.
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.
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.
Medline Industries is recalling five models of urology convenience kits due to calibration issues in sterilization and packaging equipment that may compromise sterility assurance.
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.
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.
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.
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 is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.
Christopher Ranch Peeled Garlic 6 oz is being recalled over potential contamination with Clostridium botulinum, due to a risk of temperature abuse during chilled storage at the firm.
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 QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
XZL Jelly Snacks in 12.68 oz bags are being recalled because the product contains undeclared FD&C Yellow #5, Yellow #6 and Red #40. 100 cases are affected.
SunRidge Farms Organic Sunset Soup Mix in 25 lb cases is being recalled over potential contamination with the pesticides haloxyfop and thiamethoxam.
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 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 has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
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.