Olympus Grasping Forceps FG-51D Recalled for Noncompliance With Force Standards
Olympus Corporation recalled 1,386 units of Disposable Grasping Forceps FG-51D due to noncompliance with force standards for opening and closing the devices.
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: This FDA Class II device recall addresses a functional defect—improper operating force—that represents a risk of harm in a surgical instrument. However, no illnesses or injuries have been reported, which qualifies this as a High-severity rather than Severe recall.
Plain-English summary
Olympus Corporation of the Americas recalled 1,386 units of Disposable Grasping Forceps, model FG-51D, which were distributed nationwide in the United States. These are surgical instruments used in endoscopic and surgical procedures.
The recalled forceps do not comply with Olympus Corporation's standards for the amount of force required to open and close the devices. This noncompliance could affect their proper operation during medical procedures.
Affected lot numbers include all production lots manufactured from January 2017 onwards. Healthcare facilities should review their inventory and contact Olympus Corporation to verify whether any devices in their supply are affected.
No illnesses or injuries related to the recalled forceps have been reported. Affected users should contact Olympus Corporation of the Americas for information on device returns, replacements, or other corrective actions.
The recalled product
- Product
- Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,386
Distribution
Distributed nationwide across the United States.
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