Abbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error
Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.
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 is classified as FDA Class II and involves a risk of harm (uneven heating) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Abbott Medical is recalling 8,940 units of the Radiofrequency Grounding Pad, REF RF-DGP-L, distributed nationwide. The recall involves specific batch numbers: 810319004, 810319005, and 810319021, identified by UDI 05415067028914.
The affected lots were manufactured with the protective release liner in an incorrect orientation. When users attempt to remove this disposable liner, a clear film may remain on the grounding pad. This residual film can interfere with patient skin contact, potentially leading to uneven heating during use.
This recall is classified as Class II by the FDA. Healthcare providers and patients should check their inventory for the specific batch numbers listed and discontinue use of affected devices. No specific instructions for disposal or replacement are provided in the source text.
The recalled product
- Product
- Radiofrequency Grounding Pad, REF RF-DGP-L
- Manufacturer
- Abbott Medical
- Affected units
- 8,940
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 (3)
- UDI: 05415067028914 Batch Numbers: 810319004
- 810319005
- and 810319021
Distribution
Distributed nationwide across the United States.
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