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.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Medtronic Navigation, Inc.-Boxborough
Class I - Dangerous
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
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.
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.
Class I - Dangerous
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.
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.
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.
Class I - Dangerous
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.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Howmedica Osteonics
Class I - Dangerous
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).
Class I - Dangerous
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
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.
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A
Medline Industries
Class I - Dangerous
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.
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.
Medline convenience kits: DAVINCI MAIN DYNJ908031D
Medline Industries
Class I - Dangerous
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Due to 11 volt Backup Battery failures.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
ARROW INTERNATIONAL
Class I - Dangerous
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.
Class I - Dangerous
Potential for overpressure alerts.
Due to 11 volt Backup Battery failures.
Class I - Dangerous
Potential for overpressure alerts.