Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. |
| Product | Allen Advance Chest Support with Pad |
| Quantity | 1,010 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom. |
| Initiated | 2023-05-18 |
| Classified | 2023-07-07 |
| Recall number | Z-2109-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-2109-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92375/
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