Baxter Healthcare Corporation recalls Adapter for Head Positioning

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.

An URGENT PRODUCT RECALL notification letter dated 4/20/26 was sent to customers. Actions to be Taken by Customers 1. Please notify all users of the product affected within your facility, especially all operating room staff. The affected Adapters may continue to be used only when mounted directly to the side rails of the operating table back plate. Do not use the Adapter on the Upper Back Section H V U side rails (component). Using the Upper Back Section H V U (separate component which is attached to the operating table s back plate) in conjunction with the Adapter accessory must be stopped/ceased, until a replacement takes place. 2. Once the newly designed Adapters are available Baxter will contact customers with instructions for return and replacement of the impacted Adapters. 3. If you received this communication directly from Baxter, acknowledge receipt by following the within the body of the corresponding email. Acknowledging receipt of this notification will prevent you from receiving repeated notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for return of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to the director of nursing, facility risk manager, patient safety, biomedical engineering department, director of surgical services, operating room staff, and any other departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of

• FDA enforcement recordOfficial FDA database entry for Z-2638-2026
• FDA device classification · GDCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4960The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.