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.
Minimum severity
Pending LLM rewrite. Source: FDA_DEVICE Z-2184-2026.
Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.
Pending LLM rewrite. Source: FDA_DEVICE Z-2164-2026.
Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.
Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.
Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.
Dexcom, Inc. is recalling Dexcom ONE+ iOS CGM App versions 1.5.0 and 1.6.0 due to a software defect that can delay glucose alerts and notifications, risking delayed detection of low or high blood sugar events.
Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.
Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.
Diowave 250W Laser Systems require a software update because some units operate at up to 70W maximum average power output, exceeding the FDA-cleared limit of 60W.
DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.
GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.
GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.
GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.
Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.