Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2184-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2185-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2186-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2187-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2188-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2189-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2190-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2191-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2192-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2193-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2194-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2195-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2196-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2197-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2198-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2199-2026
Open, ClassifiedPosted May 12, 2026·Initiated Apr 9, 2026
Thermedx FluidSmart Urology Tube Set REF LL0006
UDI-DI code: 00860936000365
The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
Reason: Due to nonconforming products being inadvertently distributed.
Root cause: Process change control
Recalling firm: Stryker CorporationType: Insufflator, HysteroscopicDistribution: U.S. Nationwide distribution in the state of GA.Recall #Z-2166-2026
Open, ClassifiedPosted May 12, 2026·Initiated Apr 8, 2026
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Root cause: Device Design
Recalling firm: Hologic, IncType: Full Field Digital, System, X-Ray, MammographicDistribution: US Nationwide distribution.Recall #Z-2167-2026 Open, ClassifiedPosted May 12, 2026·Initiated Apr 8, 2026
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Root cause: Device Design
Recalling firm: Hologic, IncType: Digital Breast TomosynthesisDistribution: US Nationwide distribution.Recall #Z-2168-2026 Open, ClassifiedPosted May 12, 2026·Initiated Apr 6, 2026
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Reason: Product has the potential for false positive results
Root cause: Under Investigation by firm
Recalling firm: Quidel CorporationType: Antigens, All Groups, Streptococcus Spp.Distribution: US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.Recall #Z-2169-2026