May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Stryker Sustainability Solutions recalls BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Hazard: Incomplete seals on sterile product
May 20, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Ca
Hazard: Out-of-specification endotoxin result that did not meet the acceptance criteria.
May 20, 2026Medical DevicesFDA
Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Hazard: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
May 20, 2026Medical DevicesFDA
Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Hazard: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
May 20, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),
Hazard: Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
May 20, 2026Medical DevicesFDA
Quidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Hazard: Product has the potential for false positive results
May 20, 2026Medical DevicesFDA
Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D
Hazard: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
May 20, 2026Medical DevicesFDA
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60
Hazard: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
May 20, 2026Medical DevicesFDA
Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to
Hazard: Due to nonconforming products being inadvertently distributed.
May 20, 2026Medical DevicesFDA
Dexcom, Inc. recalls Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe
Hazard: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
May 20, 2026Medical DevicesFDA
Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe
Hazard: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
May 20, 2026Medical DevicesFDA
Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S
Hazard: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.