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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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