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
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety responsibilities.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.
Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.
One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.
Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.
A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.
Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.
DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.
North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.
Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.
Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.
MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.
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.