Hazard
163 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 163 quality control failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (5%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality control failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.
Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.
VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Equate Maximum Strength Lidocaine Pain Relieving Patches (4%) are being recalled due to current Good Manufacturing Practice deviations. Approximately 1.1 million patches were distributed nationwide in the US.
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.
A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.
DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.
EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.
A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.
Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.
A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.
A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.
A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.