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
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
Braun ThermoScan PRO 6000 ear thermometers may overheat if exposed to fluids and used before drying, risking burns to the user or patient. More than 1 million units are affected.
BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.
BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.
The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.
Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.
Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.
Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.
BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.
CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.
Cellex is recalling approximately 44,821 units of its qSARS-CoV-2 Antigen Rapid Test due to lack of FDA emergency use authorization. The test was distributed nationwide in California, Florida, Texas, and Wisconsin.
Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.
Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.
Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.
Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.
Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.
Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.
Cypress Medical Products is recalling one case of McKesson Lap Sponges due to a failed sterilization indicator that did not change from red to blue, compromising verification of proper sterilization.
Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.