Surgical Table Cushion — Class II medical device recall Z-1925-2016
Terminated recall by Berchtold Corp., reported 2016-06-15, distributed nationwide. The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabr
| Recall number | Z-1925-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Berchtold Corp., Charleston, SC, United States |
| Recall initiated | 2016-04-19 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Quantity | 227 units |
Product
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
Reason for recall
The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.
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-1925-2016. 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.