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.
AvKARE Inc. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, because the medication was found to be subpotent.
Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.
AvKARE Inc. is voluntarily recalling 214 unit dose packs of Quinapril 5 mg tablets nationwide because the medication is subpotent.
Nanophase Technologies is recalling 4,104 cartons of Z-COTE HP 1 Transparent Zinc Oxide powder due to illegible labels where writing is rubbing off.
Alivecor is recalling Alive ECG App version 2.1.2 for iOS because the application crashes upon use.
Stryker is recalling Flyte Togas with an incorrect expiration date. The label reads 2412-12-01 instead of 2014-12-01.
Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components because the product labeling does not specify the 5-year shelf life.
MAST Biosurgery is recalling 49 units of SurgiWrap Bioresorbable Adhesion Barrier Film because the expiration date on the barcode did not match the printed date.
Synthes, Inc. is recalling 38 units of Hemostatic Bone Putty because Revision A of the brochure was distributed instead of the corrected Revision B.
Lacrimedics Inc is recalling VisiPlugST devices because moisture levels may cause the plugs to break apart or crumble upon contact.
The Harvard Drug Group is recalling Thera Tablets with Beta Carotene because some blister cards are missing product information on the back.
Krehbiels Specialty Meats is recalling approximately 29 pounds of pork bratwurst because the label failed to list all ingredients due to a printing error.
Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.
Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.
Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.
Aptalis Pharmatech Inc. is recalling approximately 49,000 Flutter Percussor respiratory devices because the packaging may be difficult to open or close.
3M ESPE is recalling 19,728 tubes of Clinpro 5000 Anti-Cavity Toothpaste because the primary boxes are missing lot numbers and expiration dates.
BMW is recalling 2014-2015 MINI Cooper Hardtop vehicles because the Tire Information Placard lists an incorrect maximum capacity weight, failing to comply with federal safety standards.
Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.
Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.
Mentor Texas, LP. is recalling 45 units of MENTOR MemoryGel Resterilizable Gel Sizers because they contain incorrect instructions for use.
Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).
Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they were manufactured 7cm shorter than specifications.
Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.