The latest headlines across every section, pulled from official and open-access sources.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. — Medtronic Navigation, Inc.-Boxborough · Class II · Ongoing · 589 units
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. — Inspire Medical Systems Inc. · Class II · Ongoing · 10 impacted units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. — Medline Industries, LP · Class II · Ongoing · 1432 units
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. — Medline Industries, LP · Class II · Ongoing · 168968 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 1,516
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 1,525,831
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. — Abiomed, Inc. · Class I · Ongoing · 10 units
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB). — Howmedica Osteonics Corp. · Class II · Ongoing · 7 units
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. — Medline Industries, LP · Class II · Ongoing · 49,654 kits total
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 62,719
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. — Medline Industries, LP · Class II · Ongoing · 72 units
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 426,041
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. — Medline Industries, LP · Class II · Ongoing · 49,654 kits total
Due to 11 volt Backup Battery failures. — Thoratec LLC · Class II · Ongoing · 694
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. — Medline Industries, LP · Class II · Ongoing · 49,654 kits total
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 180
Potential for overpressure alerts. — ConMed Corporation · Class II · Ongoing · 1,261 packs (7,566 eaches)
Due to 11 volt Backup Battery failures. — Thoratec LLC · Class II · Ongoing · 4
Potential for overpressure alerts. — ConMed Corporation · Class II · Ongoing · 36,462 packs (219,850 eaches)
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 126,530
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. — ARROW INTERNATIONAL, LLC · Class I · Ongoing · 37,738
Potential for overpressure alerts. — ConMed Corporation · Class II · Ongoing · 71,151 packs (426,908 eaches)
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. — Medline Industries, LP · Class II · Ongoing · 49,654 kits total
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. — Medline Industries, LP · Class II · Ongoing · 20 units