Class IOngoingZ-0532-2026
Glycar SA Pty., Ltd. recalls SJM Pericardial Patch
The impacted lot may not meet the required tensile strength specification.
Glycar SA Pty., Ltd.Dec 3, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 229–240 of 595 recalls
Class IOngoingZ-0531-2026
Glycar SA Pty., Ltd. recalls SJM Pericardial Patch
The impacted lot may not meet the required tensile strength specification.
Glycar SA Pty., Ltd.Dec 3, 2025
Class IOngoingZ-0488-2026
TMJ Solutions Inc recalls TMJ Bilateral Implant REF: CHG020 Sterile EO
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
TMJ Solutions IncCANov 26, 2025
Class IOngoingZ-0430-2026
CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate;…
CareFusion 303, Inc.CANov 26, 2025
Class IOngoingZ-0451-2026
Medline Industries, LP recalls Convenience kits
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0450-2026
Medline Industries, LP recalls Convenience kits
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0449-2026
Medline Industries, LP recalls Anesthesia circuit kit
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0448-2026
Medline Industries, LP recalls Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909…
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0447-2026
Medline Industries, LP recalls Convenience Kit
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0446-2026
Medline Industries, LP recalls DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAR…
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0445-2026
Medline Industries, LP recalls Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025
Class IOngoingZ-0444-2026
Medline Industries, LP recalls Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Medline Industries, LPILNov 19, 2025