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
Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.
Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.
Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.
Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.
Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.
Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.
Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.
Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.
Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.
The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.
Beckman Coulter recalls Access Thyroglobulin Calibrators that cause approximately 11% decrease in patient test results. The recall affects about 5,980 units distributed worldwide except the US, Canada, and China.
RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.
The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.
Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.
Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.
Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.
Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.
Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.