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.
Verathon recalls GlideScope Go Monitors due to failure to meet IP67 waterproof rating, which may allow fluid ingress and loss of functionality.
Blount Fine Foods is recalling specific lots of Panera BREAD at HOME Chicken Tortilla Soup due to possible contamination with pieces of gray nitrile glove.
API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
Del Monte Foods is recalling Del Monte Fresh Cut Golden Sweet Whole Kernel Corn due to post-process spoilage discovered in some containers during inspection at a distribution center.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.
NOW Health Group Inc. is recalling a specific lot of Organic Steel Cut Oats that may contain Organic Beet Sugar instead of the labeled product. Affected consumers should not consume the product.
API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.
Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs because they were manufactured out of specification, potentially affecting laboratory test accuracy. The recall involves 327 units distributed nationwide and to Bermuda.
CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other countries.
Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.
Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.
Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.
Teligent Pharma, Inc. is recalling Erythromycin Topical Gel 2% due to failed impurities and degradation specifications. The recall affects approximately 22,824 tubes distributed nationwide.
Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.
GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.
B Force, a homeopathic oral supplement containing multiple active ingredients, is being recalled because it is superpotent. The product was distributed in Florida.
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.
The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.
Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.
Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.
Rite Aid is recalling about 9,780 rechargeable handheld fans sold nationwide from April through June 2021 because the lithium ion battery can overheat while charging and pose a fire hazard. The company has received two reports of the fans overheating and emitting smoke, though no injuries have been reported.
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.
GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.