Z-2638-2026Class II

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of...

Name: Z-2638-2026 Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of...
Creator: Baxter Healthcare Corporation
Published: 2026-04-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-04-21 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product... on 2026-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2638-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-21
Posted: 2026-07-01
Recalling firm: Baxter Healthcare Corporation
Product: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 13 units
Distribution: Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.
Product codes and lots: Lot Code: Product Code: 1739994 UDI-DI: 00887761972780 Serial Numbers: 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2638-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2638-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)