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.
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 Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.
Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Jolife AB is recalling 153 LUCAS chest compression systems (Models 2, 3, and 3.1) due to incomplete service documentation. Service work performed on affected systems was not properly documented in service records.
Ascend Laboratories is recalling 17,304 bottles of Metoprolol Succinate Extended-Release 25 mg tablets (Lot #25140859, expiring Jan 2027) distributed nationwide because the tablets failed dissolution specifications, which may affect drug effectiveness.
Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.
DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (Model 11-1424) due to a broken connector that may interrupt prescribed cold therapy treatment.
GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.
Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.
Hologic is recalling certain 3DIMENSIONS MAMMOGRAPHY SYSTEM models due to internal bolts that may become loose, missing, or broken over time. The FDA classified this as a Class II recall.
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.
DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.
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.
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel 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.
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.
DJO, LLC is recalling DONJOY ICEMAN CLASSIC CUBE cold therapy units due to broken connectors that may interrupt prescribed cold therapy. Approximately 596 units were distributed nationwide and in Canada.
GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected worldwide.
GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.
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.
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.