Z-1925-2016Class II

Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table...

Name: Z-1925-2016 Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table...
Creator: Berchtold Corp.
Published: 2016-04-19
License: https://open.fda.gov/license/

Berchtold Corp. / initiated 2016-04-19 / Terminated / root cause: manufacturing process

FDA source

Berchtold Corp. began a recall of 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... on 2016-04-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1925-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-19
Posted: 2016-06-07
Terminated: 2017-03-31
Recalling firm: Berchtold Corp.
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.
Product code: LWG Surgical Table Cushion
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Berchtold Corporation sent an Urgent Medical Device Recall letter dated April 19, 2016, to all affected customers. The consignees were instructed to return the enclosed acknowledgment form by email to [email protected] and then discard the HybiGel Pads.
Quantity in commerce: 227 units
Distribution: Nationwide Distribution
Product codes and lots: 141364, 141365, 141367, 141369, 142575, 142577, 142579, 142769, 142771, 142773, 142774, 142775, 143420, 144088, 144384, 144447, 145384, 145529, 145545, 145936, 146141, 146963, 147304, 147305, 147306

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code LWG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)