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.
Bracco Diagnostics is recalling 47,750 vials of Multihance injection due to a potential underfill of the product.
Baxter Healthcare is recalling 19,380 Mini-Infuser Model 300XL infusion pumps because a battery contact defect may prevent the device from operating.
Morton Salt Co. is recalling specific lots of Sodium Chloride USP due to slightly out-of-specification bromide levels.
Sunquest Information Systems is recalling Encompass software versions 2.4 and later because specimen collection times display one hour late during Daylight Saving Time.
Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.
Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues regarding product documentation and classification identified during a merger review.
Hill Dermaceuticals is recalling 111,816 bottles of Derma-Smoothe/FS Body Oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.
American Health Packaging is recalling Topiramate Tablets due to a labeling error that incorrectly identifies the product as capsules.
Hospira Inc. is recalling 77,542 vials of Carboplatin Injection because the active ingredient lots trended out of specification for low pH.
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.3.0 and later because test results may be filed to the wrong patient containers.
Terumo is recalling three Sarns System 8000 bases because they were distributed with incorrect amperage ratings on the nameplate labels.
Teleflex Medical is recalling 611 units of TAUT Cholangiogram Catheter Intraducers because the internal packaging is missing labels. The devices were distributed to 27 states.
Vogue Tyre & Rubber Company is recalling certain Custom Built and Signature V tires because they lack the required tire identification number on the sidewall.
Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.
Berchtold Corp. is recalling 17 Chromovision HD Wireless Cameras because loose wire connections may cause image distortion or loss during surgical procedures.
Impact Instrumentation is recalling ten Model 731 EMV+ Uni-Vent devices shipped before verification of a new integrated circuit was completed.
Siemens is recalling Dimension Vista Vancomycin Reagent Cartridges because calibration failures prevent the vancomycin assay from running.
Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.
Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Infants' Mapap in Michigan because the outer packaging displays an incorrect expiration date.
Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.
Fougera Pharmaceuticals is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, due to potential trace contamination with Di-Octyl Phthalate.
Stat Rx USA is recalling 51 bottles of Tizanidine 4 mg tablets because some labels incorrectly identified Actavis as the manufacturer.
JHP Pharmaceuticals is recalling specific lots of Pitocin (Oxytocin) injection due to a labeling error that displays an incorrect lower storage temperature limit.
Vintage Pharmaceuticals is recalling 73,746 bottles of Hydroxyzine Hydrochloride Oral Solution because high levels of a known impurity were detected.
Pack Pharmaceuticals is voluntarily recalling 4,848 bottles of Ciprofloxacin 500 mg tablets because two bottles were found missing container labels.