Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.
Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.
Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.
Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.
Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.
DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.
CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.
Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.
Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.
Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.
DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.
DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.
DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.
CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.
Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.
Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.