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
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.
Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.
Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.
Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.
Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.
Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.
Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.
Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.
Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.
The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.
DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.
Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.
The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.
Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.
Steris Corporation recalls Medivators Advantage endoscope hookup accessories because identification labels become illegible as ink degrades, potentially preventing proper hookup identification and delaying patient procedures.