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.
Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.
Lupin Pharmaceuticals is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen tablets in Ohio due to missing labels.
Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.
Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.
Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.
Milbar Laboratories is voluntarily recalling 952 bottles of T Shampoo For Hair and Body because the product is subpotent.
Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.
Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.
LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.
Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.
Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.
Uno Foods Inc. is recalling 1,881 pounds of ham and cheese calzones because the packages contain buffalo chicken calzones instead.
Boiron Inc. is recalling 52,810 tubes of Calendula Cream because the outer carton incorrectly lists the active ingredient concentration as 7% instead of 10%.
Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets distributed in Florida because foreign tablets or capsules were found in the product.
Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to identified labeling discrepancies in the patient literature.
Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.
Septodont Inc. is recalling OraVerse (Phentolamine Mesylate) Injection due to an out-of-specification result for a degradation product impurity.
Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.
MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.
Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.
Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Cards because the box label incorrectly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCA).
Beijing Syntech Laser Co., Ltd is recalling 13 Diode Laser surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.