Edwards Lifesciences Recalls Mislabelled Ergonic Double Acting DeBakey Forceps
Edwards Lifesciences is recalling three units of Ergonic Double Acting DeBakey Forceps due to incorrect laser etching that misidentified the instrument type.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a labeling error (mislabeling) rather than a functional defect or contamination.
Plain-English summary
Edwards Lifesciences, LLC is recalling three units of the Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip, Model Number ERGF01330. The recall involves Lot Number 11211566.1 with an expiration date of 09/01/2017. These surgical instruments are designed for specialized functions in specific cardiac surgical or endoscopic procedures.
The recall was initiated because the devices were mislabeled. Specifically, Ergonic scissors with a standard curved tip were incorrectly labeled as Double Acting DeBakey forceps. Edwards Lifesciences confirmed that the laser etching on the devices was incorrect.
The affected units were distributed to three customers in Florida. Consumers and healthcare facilities should check their inventory for this specific model and lot number. If found, the instruments should be removed from use and returned to the distributor or manufacturer according to recall instructions.
The recalled product
- Product
- Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 3
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 (2)
- Lot Number: 11211566.1
- Exp. Date: 09/01/2017.
Distribution
Distributed in 1 state:
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