FDA recalls affect surgical staplers, OR procedure kits, ultrasound systems used in hospitals

Editor's Note

The Food and Drug Administration (FDA) has announced three new recalls between October 14 and 16 that may affect OR inventory and perioperative workflows across multiple service lines. Each recall targets a commonly used product in surgical or imaging settings, prompting leaders to review supplies and coordinate with clinical and biomedical teams.

According to an FDA recall notice published on October 14, Ethicon initiated a Class II recall of its ECHELON 80 mm Blue Reloads, used with linear cutters for tissue transection and resection. The recall reason states the “devices were shipped unsterilized” and cites potential device performance issues that could affect staple line integrity during procedures. Facilities using Ethicon staplers for general, thoracic, or colorectal surgery are advised to identify affected lots and follow the company’s return instructions.

Per several recall reports dated October 16, American Contract Systems recalled multiple sterile “medical convenience kits,” including laminectomy, cardiovascular, gynecologic laparoscopic, cesarean section, and other specialty packs, because the “identified products were re-gassed (sterilized more than once).” These kits are frequently used in surgical suites and procedural areas. The recall affects numerous lot numbers distributed to hospitals and ambulatory surgical centers nationwide. Facilities are directed to quarantine and replace affected kits to avoid day-of-surgery disruptions.

Separately, on October 15, the FDA listed a recall for GE Medical Systems LOGIQ P9 and P10 ultrasound systems running software version R4.5.7 because “measurement data may display inaccurate values representing liver steatosis.” These devices are often used for regional anesthesia guidance, intraoperative imaging, and point-of-care diagnostics. The recall addresses a software issue that may impact imaging reliability, and GE has notified customers of the corrective action plan. Biomedical and anesthesia departments should verify device versions and coordinate with GE for updates or replacements.

Each of these recalls involves Class II actions, meaning use of the products could cause temporary or medically reversible adverse effects or carry a remote risk of serious injury. OR supply chain and safety leaders should confirm receipt of manufacturer notices, update recall tracking logs, and communicate with clinical stakeholders to mitigate procedural risk.