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 the agency’s own highest classification or reported deaths or serious injuries, 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
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.
GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.
Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.
Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.
Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.
Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.
Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.
Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.
Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.
Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.
Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.
Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.
Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.
Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.