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.
Campo Rico Foods LLC is recalling 11 cases of Kanni Delight frozen shrimp because nitrofurans were detected in the product.
Cheer Pack is recalling certain flexible food pouches because they may release thin plastic strips into food products.
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.
Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
PT Organics Limited is recalling certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree pouches due to the potential presence of thin, soft plastic strands.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Terex Utilities is recalling Power Over Fiber Base Modules because the devices lack proper laser certification and contain incorrect safety labeling regarding their laser class.
Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Glenmark Pharmaceuticals is recalling azelaic acid gel 15% after receiving complaints that the product felt grainy, gritty, or sandy. The nationwide recall covers specific lots with expiration dates from February through April 2028.
Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was recalled for supplier quality issues.
Windstone Medical Packaging is recalling 3,378 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP because the lidocaine was recalled due to supplier quality issues.
Wabash is recalling 2027 Van Trailers because the external ABS malfunction indicator light may lack a label, potentially confusing other drivers.
Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.
Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.
Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.