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.
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
La Michoacana Rompope ice cream bars are being recalled due to undeclared Yellow #5, Yellow #6, and Red #40. The product was distributed only in Florida.
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
TJX is recalling about 29,000 foldable wood and rope bistro set chairs because the wooden frame can break or collapse when occupied, creating a fall hazard. The company has received eight reports of frame breakage, including six reports of minor injuries such as bruising and ankle strain.
Ben E Keith Foods recalls 1721 cases of frozen bread products that experienced temperature abuse during truck shipment to food services. Products include sandwich bread, dinner rolls, and hamburger buns.
Votrient (pazopanib hydrochloride) 200 mg tablets are being recalled nationwide. Three lot numbers failed to meet dissolution specifications.
Ben E Keith Foods recalls approximately 1,721 cases of frozen and refrigerated food products due to temperature abuse during distribution to food services.
Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.
E.A. Sween Co. is recalling Deli Express Deli Club sandwiches (lot U023236) due to label mix-up with inaccurate required label information. The recall affects 31,550 units distributed across 19 states.
BC Gourmet USA is recalling Hungry Root Creamy Vodka Sauce (10.5 oz Plastic Cup) due to the presence of yeast and mold. The affected product was distributed in California, New Jersey, and Indiana.
BC Gourmet USA, Inc. is recalling 81,312 units of Hungry Root Marinara Sauce due to yeast and mold contamination. Affected products were distributed in California, New Jersey, and Indiana.
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
Traeger is recalling about 37,000 Flatrock Flat Top Propane Grills because burner control knobs can be incorrectly labeled, allowing the grill to be unintentionally left on and posing a fire hazard. No fires or injuries have been reported.
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
BAPS Shayona is recalling approximately 674 units of Motichur Ladoo across six states due to undeclared Yellow #5 and Yellow #6 food dyes discovered during an FDA inspection.
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.