Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.
Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.
Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.
Woodbine Products is recalling FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH due to incorrect scent information on the label. The affected lots VDAF017 and VDAF018 were distributed in North Carolina, and no illnesses have been reported.
Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.
TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.
Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.
BIOPHEN UFH Control Plasma boxes contain incorrect product labeling. Aniara Diagnostica LLC is recalling 13 units (Lot FA2035) distributed in Illinois and Michigan.
Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.
Juice Beauty The Organic Solution SPF 8 lip moisturizer is being recalled due to failed dissolution specifications. The recall affects 35,313 tubes distributed in California.
Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.
Abbott Laboratories is recalling approximately 121,918 cases of Pedialyte with Immune Support Raspberry Lemonade due to potential container leakage. The recall affects multiple states.
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Bestco LLC is recalling Open Nature Cough Drops (Menthol flavor) due to insufficient menthol content. Products may not be effective as labeled.
Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
HumbleHungryHappy LLC is recalling Marine Corps Mash packaged meals (9.8 oz and 13.8 oz) distributed in Oregon and online because the product declares fish as an allergen but does not specify the type of fish.
HumbleHungryHappy LLC recalls 97 containers of Bison Breakfast due to incomplete allergen labeling: the product declares Fish but does not specify which fish. Consumers with fish allergies may not have adequate warning.
Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1mg/mL injection vials distributed nationwide because the product is sub-potent (below specified strength). The firm initiated this voluntary recall on March 8, 2022.