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.
NRS Enterprises, Inc. is recalling German Home Bakery Cherry Coffee Cake due to undeclared Yellow #5. The product was distributed in California and may affect consumers with tartrazine sensitivity.
Pure Brands of California is recalling Purefog High Density Natural Fog Juice Liquid because the product can expire sooner than the printed expiration date, posing a mold-exposure risk to people with compromised immune systems, damaged lungs, or mold allergies.
Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.
Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.
Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.
Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.
Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.
Natus Neurology is recalling Sleep Supplies Start Kits due to defective conductive adhesive gel supplied by Parker Laboratories. The gel is too thick, discolored, and caused patient irritation in at least one case.
Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.
Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.
Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.
A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.
Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.
Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.
Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.
Landauer is permanently discontinuing the microStar Reader medical dosimetry system. The company is removing product documentation references and discontinuing use with medical dosimeters.
Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.
Sun Pharmaceutical is recalling 7,488 bottles of Febuxostat 80mg tablets nationwide due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
Peter Lazic Gmbh is recalling 170 L-Aneurysm Clip TITANIUM Paddle-Clips distributed in Maine due to incorrect blue coloring instead of blank.
Lidl US TRADING is recalling Banana Pepper Rings due to punctured lids on glass jars, which may compromise product integrity. Affected jars were distributed across multiple states in the Mid-Atlantic and Southeast regions.
Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.
Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.
Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bars are being recalled because milk is not properly declared on the packaging. The recall affects 1,644 bars distributed in California, Florida, Pennsylvania, and North Carolina.
Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.
Vitony Bakery cheesecake products are being recalled due to undeclared FD&C Yellow #5 and Yellow #6 dyes. The recall affects 6,916 units distributed to Puerto Rico and may pose risks to consumers with sensitivities to these colorants.