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.
Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.
Arrow International Inc. is recalling 1,150 units of FlexTip Plus Combined Spinal Epidural Catheterization Kits because the product lidstock contains the incorrect expiration date.
LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.
Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.
Par Pharmaceutical is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, because they are labeled with an incorrect expiration date.
Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.
Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two Neodent Tapered Guided Surgery Drills because the laser engraving incorrectly identifies the model.
Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from container labels. This is a precautionary measure.
GE Healthcare is recalling 62 SIGNA Pioneer MRI systems because an installation issue may cause incorrect dates on medical images.
Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.
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.
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.
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.
Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.
Nidek, Inc. is recalling 13 Specular Microscopes, Model CEM-530, because their electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard.
Island Kinetics is recalling PCA Skin Blemish Control Bar because the salicylic acid content exceeds the firm's specifications.
Chicken of the Sea is recalling specific cans of sardines because they were labeled as 'in Water' but actually contain tomato sauce.
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.
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 two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
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 voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.
Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.