The Recall Desk
HighFDA (Devices)·Z-1925-2016·Announced 2016-06-15

Berchtold Recalls Surgical Table Cushions Due to Potential Staple Contamination

Berchtold Corp. is recalling 227 HybriGel surgical table cushions because they may contain staples that could appear on patient x-rays.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but the presence of foreign objects (staples) could interfere with diagnostic imaging, fitting the 'High' severity criteria for potential harm without confirmed illness.

Plain-English summary

Berchtold Corp. is recalling 227 units of Surgical Table Cushions (HybriGel Pads) distributed nationwide. These pads are optional accessories for the Operon Surgical Table and attach to the base section using Velcro fasteners.

The recall was initiated because the cushions could potentially contain staples used to secure two underlying fabrics. If present, these staples could be captured on certain patient scans, such as x-rays, potentially interfering with medical imaging.

Healthcare facilities should stop using the affected HybriGel pads immediately. The affected units are identified by specific code numbers listed in the recall documentation. Users should contact Berchtold Corp. for instructions on returning or replacing the products.

The recalled product

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.
Manufacturer
Berchtold Corp.
Affected units
227

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 141364
  • 141365
  • 141367
  • 141369
  • 142575
  • 142577
  • 142579
  • 142769
  • 142771
  • 142773
  • 142774
  • 142775
  • 143420
  • 144088
  • 144384
  • 144447
  • 145384
  • 145529
  • 145545
  • 145936

Distribution

Distributed nationwide across the United States.