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.
Teleflex Medical is recalling RuSCH One piece Male External Regular Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.
AuroMedics Pharma LLC is recalling Moxifloxacin Ophthalmic Solution due to market complaints of discoloration. The affected product is distributed nationwide in the U.S.
Teleflex Medical is recalling RuSCH One piece Male External Medium Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.
Lupin Pharmaceuticals is recalling specific lots of Tri-Lo-Marzia oral contraceptives due to out-of-specification test results found during a retrospective review of blend uniformity data.
Idelle Labs is recalling SURE 48hr Confidence Nourishing Coconut Antiperspirant & Deodorant because the label lists an active ingredient that is not actually in the product.
Chicken of the Sea is recalling specific cans of sardines because they were labeled as 'in Water' but actually contain tomato sauce.
Nidek, Inc. is recalling 13 Specular Microscopes, Model CEM-530, because their electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard.
Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.
Island Kinetics is recalling PCA Skin Blemish Control Bar because the salicylic acid content exceeds the firm's specifications.
Pharmedium Services LLC is voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.
Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.
AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.
Pharmedium Services LLC is recalling 5,808 bags of Repinephrine Bitartrate Injection due to subpotent drug levels. The FDA classified this as a Class III recall.
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.
Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.
Apothecus Pharmaceutical Corp. is recalling VCF Vaginal Contraceptive Foam cans and case packs because the canister units exhibit propellant leakage, rendering the product unusable.
Allergan is recalling Natrelle saline-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.
Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.
Allergan is recalling NATRELLE Resterilizable Sizers because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.
Allergan is recalling Natrelle Inspira silicone-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.
Huy Fong Foods is recalling 20,235 cases of Sriracha HOT Chili Sauce because the top seal bulged and exploded when removed.
Glenmark Pharmaceuticals is recalling Clobetasol Propionate Foam because the product is not foaming or is coming out as liquid.
Glenmark Pharmaceuticals is recalling Clobetasol Propionate Foam because the product is not foaming or is coming out as liquid.
Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.