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
Philips Brilliance iCT CT scanners are recalled because fasteners securing the rotor may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or displaced.
Medline 14 Fr Suction Catheter Kits may contain an 8 Fr catheter instead, potentially causing airway obstruction and respiratory failure. The kits were distributed nationwide and in Canada.
Philips is recalling 283 Spectral CT scanners because fasteners that attach the rotor to the gantry bearing may not be properly torqued, potentially allowing rotor parts to become loose or displaced during operation.
Philips is recalling the Azurion 3 M15 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when locked. This poses a patient safety hazard during interventional procedures.
Philips is recalling 52 IQon Spectral CT scanners because fasteners attaching the rotor may not be properly torqued, potentially allowing rotor parts to become displaced or expelled during operation.
A firmware defect in the da Vinci 5 Surgeon Console Viewer Display may cause loss of one or both displays during surgery. When visualization is lost, surgical instruments remain active, risking tissue injury and bleeding.
Surepulse Medical is recalling the VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to incorrect sizing information in the labeling.
Surepulse Medical recalls VS Cap Small components of newborn heart rate monitors due to incorrect sizing guidance in the labeling. The labeling error could affect proper device fit.
Medline Industries is recalling 2,448 suture removal kits due to potentially open packaging seals on BD ChloraPrep Triple Swabsticks applicators, which could compromise sterility.
The Surepulse VS Cap Extra Large component of newborn heart rate monitors has been recalled because the product labeling contains an incorrect sizing guide.
Medline Industries is recalling 7,570 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potentially open seals on applicator packaging. The kits are distributed nationwide to hospital and clinical settings.
Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.
Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.
Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.
Boston Scientific is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion failures that may require additional surgical or endoscopic intervention.
Boston Scientific is recalling AXIOS stents due to reported deployment and expansion issues. The devices may fail to expand properly during procedures, potentially requiring additional surgical intervention.
Boston Scientific is recalling 588 units of HOT AXIOS biliary stents worldwide due to reports of deployment and expansion failures that may require additional endoscopic or surgical intervention.
FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.
Boston Scientific is recalling 266 units of the HOT AXIOS Stent due to deployment and expansion issues that may require additional surgical intervention to remove the stent and close the puncture site.
Boston Scientific recalls HOT AXIOS 8mm stent delivery system for deployment and expansion failures. The devices may require surgical intervention to remove the stent and close puncture sites.
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results that could incorrectly classify patients as having or not having Alzheimer's amyloid pathology.
Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.
Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to elevated background counts in platelet Daily Checks when used with UniCel DxH analyzers. This can affect test result accuracy.
Focalyx Fusion prostate imaging devices may not work properly on Windows 10, risking patient harm during biopsy or treatment delays. The manufacturer recommends stopping use until Windows 11 compatibility is verified.