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
FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.
FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.
Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.
Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.
FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.
Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.
Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.
Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.
Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.
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.
BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.
Howmedica Osteonics Corp. is recalling X3 Triathlon inserts due to potential breaches in sterile packaging. The breach could compromise device sterility and allow contamination if the affected units are used.
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.
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 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.
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.
Synapse PACS Version 7.1.000 medical imaging software produces incorrect measurements when Secondary Capture 2D images without pixel spacing are combined with Breast Tomo Series data.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
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.