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
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
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.
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
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.
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
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.
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
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.
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.
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.
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 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.
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.
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.