Recalls and safety alerts from the FDA, newest first.
SKS Copack of Cerritos, CA is recalling various specialty beverages, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy per
Kettle Cuisine of Lynn, MA is recalling 24oz cups of Whole Foods Market Kitchen Minestrone Soup which may contain undeclared shrimp. People who have allergies to Crustacean Shellfish (Shrimp) run the risk of serious or life-threatening allergic reaction if they consume this product.
Certain labels used with i.v.STATION automated compounding systems may not be detected, leading to mislabeled sterile filled syringes.
FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. — Oasis Medical, Inc. · Class II · Ongoing
Crystallization; identified as Buprenorphine free base — ENDO USA, Inc. · Class II · Ongoing · 34,293 vials
Failed Dissolution Specifications — Ascend Laboratories, LLC · Class II · Ongoing · 17,304 100-count bottles
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
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. — GE Medical Systems, LLC · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolizat… — MICROVENTION INC. · Class II · Ongoing
Due to broken connector which may result in a temporary interruption of prescribed cold therapy. — DJO, LLC · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. — Hologic, Inc · Class II · Ongoing
Potential for mislabeled syringe produced by the i.v.STATION device. — Omnicell, Inc. · Class I · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
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. — GE Medical Systems, LLC · Class II · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Medline has identified the presence of particulate within the fluid path of the Manifolds. — Medline Industries, LP · Class I · Ongoing
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time… — Medtronic Neuromodulation · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing
Incomplete seals on sterile product — Stryker Sustainability Solutions · Class II · Ongoing