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
Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.
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.
Universal Meditech is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.
Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.
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.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
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.