Boston Scientific ICEfx Cryoablation System Recalled for 19 Units Worldwide (2025)
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2,756 recalls tagged with “immediate action”.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.
Product may be contaminated with Cesium-137 (Cs-137)
Product may be contaminated with Cesium-137 (Cs-137)
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Product may be contaminated with Cesium-137 (Cs-137)
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.