Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential breach of sterile packaging, which is a low-risk contamination issue in the absence of reported infections or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Gyrus Medical, Inc. is recalling 1,140 units of GYRUS ACMI Everest BiCOAG Bipolar Dissecting Forceps (REF 3740, 3740PK, and 94201PK). These sterile, single-use electrosurgical devices are indicated for coagulation, grasping, and dissection during laparoscopic and general surgical procedures. The products were distributed nationwide in the United States and in Brazil, China, Australia, Germany, and India.
The recall was initiated after an accelerated aging study conducted as part of a new market submission found that one of 60 tested units failed a dye penetration test. This failure indicated that the seal on the sterile packaging was compromised. The products are labeled with a 3-year shelf life, and the study simulated this aging period.
Healthcare providers and patients should stop using the affected units and contact Gyrus Medical for instructions on return or replacement. The recall is limited to the specific reference numbers and lot codes listed in the official notice.
The recalled product
- Product
- GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the…
- Manufacturer
- Gyrus Medical, Inc
- Hazard
- Affected units
- 1,140
Distribution
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