Z-2638-2026 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-2638-2026 was initiated by Baxter Healthcare Corporation on Apr 21, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13 units.

Recall details

Product Type
Devices
Report Date
Jul 8, 2026
Initiation Date
Apr 21, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 units

Product description

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

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.

Distribution pattern

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.

Code information

Lot Code: Product Code: 1739994 UDI-DI: 00887761972780 Serial Numbers: 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2638-2026
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-2638-2026. Report a data issue: hello@regdatalab.com.