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
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.
Stryker is recalling Nail Insertion Sleeves with incorrect inner diameters that do not match the box label. The dimensional mismatch could affect proper fit during orthopedic surgical procedures.
ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.
Abbott Laboratories is recalling its Alinity c Activated Alanine Aminotransferase reagent kit due to potential analytical errors that could produce incorrect test results. The issue affects certain lot numbers distributed worldwide.
The Regard Newborn Kit heel warmer is being recalled. Updated instructions now require that the device be activated away from the user's face and away from the infant and others.
Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold prior to December 9, 2019.
Abbott's A-ALT laboratory reagent may produce inaccurate results in samples with very high enzyme levels or elevated bilirubin, potentially affecting patient diagnoses. The affected product (REF 8L92-21) was distributed worldwide.
Verathon recalls GlideScope Go Monitors due to failure to meet IP67 waterproof rating, which may allow fluid ingress and loss of functionality.
Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.
Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.
Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.
Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.
Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.
ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.
Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.
Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.
Sunrise Medical is recalling the Zippie Voyage early intervention stroller due to unexpected seating system detachment that can cause falls and injury. Approximately 4,741 devices are affected worldwide.
Sunrise Medical recalls Zippie Voyage early intervention strollers because the seating system may unexpectedly detach and fall, causing injury. Approximately 9,865 devices are affected.
Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.
GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.
Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.
CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.
The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.