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.
Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.
Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.
Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.
Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.
R & S Roberts Enterprises recalls Milk & Dark Chocolate Sea Salt Caramels due to undeclared soy lecithin used in the releasing agent. The product may cause reactions in consumers with soy allergies.
Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.
Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
DGL Group is recalling approximately 93,000 Hover-1 Superfly Hoverboards sold between October 2020 and October 2021 at Best Buy due to a software malfunction that causes uncontrolled momentum when the rider is not actively controlling the board.
Moderne Glass Company is recalling about 2,500 ceramic coffee cups that can crack or break when hot water is poured into them, posing a burn hazard. No injuries have been reported. Consumers should stop using the cups immediately and contact the company for a refund.
Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate USP used for prescription compounding because the product is subpotent, containing less active ingredient than expected. The recall is nationwide.
Eastland Food Corporation is recalling Bwell Bird's Nest Beverage Honey Flavor because deficient packaging may cause premature spoilage. The product was distributed to retail stores in 34 states.
Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.
Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.
Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed nationwide.
Eastland Food Corporation is recalling Bwell Bird's Nest Beverage Coconut Flavor due to deficient packaging material that could lead to premature spoilage. Approximately 1,699 cases were distributed to retail stores across multiple states.
Sun Pharmaceutical is recalling Bupropion Extended-Release 200mg tablets after customers found activated carbon particles inside bottles from the desiccant canister.
Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.
American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.
Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate USP for prescription compounding due to subpotency. The affected lots were distributed nationwide.
Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.
Bwell Bird's Nest Beverage Sugar-Free Xylitol is recalled due to deficient packaging material that may lead to premature spoilage. The FDA Class II recall affects 1,699 cases distributed across 34 U.S. states.
Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.
Bwell Bird's Nest Beverage Pandan Flavor is being recalled due to deficient packaging material that may lead to premature spoilage. The recall affects 1,699 cases distributed to retail stores across 33 states.