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
Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.
Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.
Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.
Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.