ESG Cutting Forceps Jaw May Fracture During Use or Inspection
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
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 is a FDA Class II medical device recall involving a risk-of-harm product (potential jaw fracture) where injury has not yet been reported. No hospitalizations, deaths, or clinical injury reports are mentioned in the source material.
Plain-English summary
Olympus Corporation of the Americas is recalling the ESG PK Cutting Forceps (Model: PK-CF0533), a surgical cutting instrument measuring 5mm in diameter and 33cm in length. This medical device is distributed and used in clinical procedures.
The jaw of the forceps may fracture either prior to the procedure during the inspection instructed in the product instructions for use (IFU), or during the procedure itself. A fractured jaw could compromise the device's function and potentially result in injury to patients or medical personnel.
Approximately 11,123 units have been distributed worldwide, including throughout the United States and internationally to Australia, Canada, Germany, Mexico, China, Singapore, and South Korea. Affected lot numbers are listed in the original FDA notice.
If you have this device in use, contact Olympus Corporation of the Americas for information on replacement, inspection protocols, or return procedures. Healthcare facilities should review their inventory against the affected lot numbers and discontinue use of affected units pending instructions from the manufacturer.
The recalled product
- Product
- ESG PK CUTTING FORCEPS, 5MM, 33CM
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 11,123
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 (20)
- Model: PK-CF0533
- UDI DI: 00821925035867
- Lot Numbers: FR258486
- FR261738
- FR259544
- FR263183
- FR276278
- FR279757
- FR279625
- FR279658
- FR286369
- FR287112
- FR374622
- FR207935
- FR212413
- FR212735
- FR215061
- FR216817
- FR220525
- FR222456
Distribution
Distributed nationwide across the United States.
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