Allen Advance Chest Support with Pad — Class II medical device recall Z-2109-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-07-19, distributed nationwide. Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating ro
| Recall number | Z-2109-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-05-18 |
| Classified | 2023-07-07 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, DK, EG, ES, FR, GB, HK, HR, IE, IL, IN, IT, JO, JP, KR, KW, LB, MY, NL, NO, PL, QA, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 1,010 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00615521003159 |
| Lot numbers | 19-134, 19-141, 19-150, 19-157, 19-161, 19-162, 19-170, 19-179, 19-190, 19-219, 19-235, 19-238, 19-287, 19-288, 19-295, 19-302, 19-326, 19-337, 19-344, 19-352, 20-009, 20-014, 20-031, 20-035, 20-042, 20-043, 20-044, 20-063, 20-064, 20-072, 20-073, 20-091, 20-223, 20-225, 20-240, 20-245, 20-259, 20-290, 20-309, 20-318 and 12 more |
| Serial numbers | 395159, 429589, A276164, A276165, A276166, A277446, A277526, A277527, A277528, A279560, A279562, A279563, A279565, A281813, A281814, A282019, A282020, A282021, A282023, A282813, A282814, A282815, A282816, A283348, A283349 and 475 more |
Product
Allen Advance Chest Support with Pad
Reason for recall
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2109-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.