Safety Recall Directory
Browse and filter the latest official safety alerts globally.
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc...
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Fotopro Bluetooth shutter remote for mobile phone camera
The remote doesn’t comply with the mandatory standards for products containing button/coin batteries . The battery isn’t secured, and children could access the button/coin battery. The product is missing warning information about: the dangers of button/coin batteries to children what to do when a person suspects someone has swallowed or placed a button/coin battery inside any part of their body.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. A...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Numbe...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Swad Mango Flavored Masala Candy
Contains undeclared Blue 1
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOL...
Incomplete seals on sterile product
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS...
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ...
Out-of-specification endotoxin result that did not meet the acceptance criteria.
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococ...
Product has the potential for false positive results
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Med...
Medline has identified the presence of particulate within the fluid path of the Manifolds.