Z-2638-2026 Class II Ongoing
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
Reason for recall
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
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