Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects
Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.
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, and the source text describes a potential compromise of sterility without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Gyrus Medical, Inc. is recalling specific models of Everest BiCOAG and PKS surgical forceps and scissors. These single-use, sterile devices are intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue during laparoscopic and general surgical procedures.
The recall is due to an anomaly in the packaging process that may result in a defective seal. This defect could allow a breach of the package's sterile barrier, potentially compromising the sterility of the product. The affected units were manufactured before July 28, 2014.
The recall involves 5,520 units in the United States and 40 units outside the US. Distribution included various US states and international locations including Italy, Spain, the United Kingdom, and China. Healthcare providers and facilities should stop using the affected products and contact Gyrus Medical for instructions on return or replacement.
The recalled product
- Product
- GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps…
- Manufacturer
- Gyrus Medical, Inc
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)
- All product manufactured before July 28
- 2014.
Distribution
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