
FDA•CRITICAL
Boston Scientific Pacemakers
Boston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
Boston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
Windstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.

B. Braun recalls STREAMLINE bloodline sets for Dialog DR over arterial line air bubble risk.
6 products
Medline recalls convenience kits with Namic RA syringes over risk of loose connection or disconnection during use.
25 productsPhilips Respironics recalls Trilogy Evo O2 ventilators (SW 1.05.15.00) over delayed obstruction alarm.
4 products
Merit Medical recalls CentrosFLO Hemodialysis Catheters over sheath introducer defect that may cause hemorrhage and other serious complications.
5 products
Baxter is issuing a correction for the Volara Respiratory Therapy system adapter module to prevent oxygen desaturation and lung injury.

Abiomed is recalling Generation 1 purge cassettes due to an increased risk of purge leaks.
2 products
Abiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
2 productsPhilips Respironics recalls Trilogy Evo ventilators over tidal volume discrepancy with non-pneumatic nebulizers.
4 products
Handy Solutions Neck & Shoulders Heating Pad (Model 25607) may overheat and cause burns if folded or placed under the body.

Erbe USA recalls Flexible Cryoprobes because probes may rupture or burst during use.
4 products
Datascope is recalling the Cardiosave battery charging station due to a screw defect in the left bay that prevents proper charging.

Insulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.

Abiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
Olympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
Straumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.

Trividia recalls TRUE METRIX meter instructions over inadequate E-5 error guidance.
7 products