Recalls and safety alerts from the FDA, newest first.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. — Think Surgical, Inc. · Class II · Ongoing · 360 devices
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. — Biomerieux Inc · Class II · Ongoing · 45,900 cards
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. — Boston Scientific Neuromodulation Corporation · Class II · Ongoing · 37,764
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 396 kits
Due to packaging discrepancy with incorrect product size mixed up. — Encore Medical, LP · Class II · Ongoing · 4
Due to packaging discrepancy with incorrect product size mixed up. — Encore Medical, LP · Class II · Ongoing · 8
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 75 kits
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. — Integra LifeSciences Corp. (NeuroSciences) · Class II · Ongoing · 633 units
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 120 units
undeclared soy — Bear Stewart Co · Class II · Ongoing · 313 cases
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 81 units
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3. — Wise Foods Inc · Class II · Ongoing · 490 cases
Potential contamination with Salmonella — Trafa Pharmaceutical Inc. · Class I · Ongoing · 500 kg
Undeclared Allergen (Soy) — Specialty Bakers, LLC · Class II · Ongoing · 449 cases
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 32 units
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella. — Fresh & Ready Foods LLC · Class I · Ongoing · 377 units
Foreign material: small metal pieces — Wondermade LLC · Class II · Ongoing · 154 boxes
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 20 units
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging. — Lehi Valley Trading Company, Inc · Class I · Ongoing · 624 plastic 15oz tubs: 585 lbs total
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella. — Fresh & Ready Foods LLC · Class I · Ongoing · 216 units
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class II · Ongoing · N/A
Medtronic issued a voluntary recall of 102 lots of its Harmony delivery catheter system due to a risk that their tips may detach, which could result in serious injury or death.
Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
Certain delivery systems that are used to insert a pulmonary valve have an increased risk of distal tip detachment, the company said. The valve itself is not affected by the recall.