Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.
Stryker is recalling 10 units of 8.0mm x 90mm Dri-Lok Threaded Cannulas because the expiration date was misprinted as August 2018 instead of August 2016.
Smiths Medical ASD Inc. is recalling 16 Bivona Tracheostomy Tubes because the cartons are labeled 'Sterile' even though the devices are not sold as sterile.
VGI Medical is recalling six VerteLP Lateral Interbody Fusion instrument kits because the included cleaning process was not validated.
Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Hobbs Medical is recalling 1,820 bronchial cytology brushes because they were marketed for uses outside their FDA clearance.
Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.
C.R. Bard is recalling specific lots of Bardex Foley catheters because the retainer cap print is incorrect.
Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.
Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.
Tyson Foods is recalling approximately 3,120 pounds of frozen breaded chicken tenderloins that may contain blue or clear soft plastic. The products were shipped to food service establishments nationwide.
NordicNeuroLab AS is recalling 97 licenses of nordicICE 2.3.14 image processing software due to a defect that may cause incorrect orientation labeling and image flipping.
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.
Joerns Healthcare is recalling 915 P.R.O. Matt and ProCair Mattresses because incorrect connectors were supplied, lacking internal shutoff valves required to prevent air loss.
Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.
Arrow International is recalling Radial Arterial Access Kits because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.
Arrow International Inc. is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
Dynarex Corporation is recalling 15 CGA870 oxygen regulators because the dial has an inaccurate flow rate indicator. The devices were distributed in Massachusetts and New Jersey.
Olsen Medical is recalling 323,886 bipolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.
Arrow International Inc. is recalling 416,055 ECG adapters because unsealed packaging may compromise product sterility.
Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.