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
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
Siemens is recalling 70 Ysio radiographic systems due to a software error that may cause unintended tube stand movement and create collision risk.
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. states.
Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
Ace Surgical Supply is recalling NuOss Collagen Blocks because some units were mistakenly packaged with Collatene Fibrillar Collagen instead, which may result in suboptimal bone repair during dental and maxillofacial procedures.