Colonoscope Recall: Missing Protective Adhesive May Cause Device Failure
Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.
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 an FDA Class II recall of a medical device with potential for harm (device malfunction) where no injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling 18 Model PCF-H180AL colonoscopes that were assembled without a protective adhesive. The adhesive is designed to protect the device from physical stress conditions including high levels of vibration, temperature fluctuations, and severe shock loads.
Without this protective adhesive, the colonoscope may be vulnerable to malfunction when exposed to these physical stresses, which could occur during shipping, storage, or use in clinical settings. No injuries or deaths have been reported to date.
This recall affects colonoscopes distributed nationwide in the United States. Healthcare facilities and clinicians using affected serial numbers should contact Olympus for instructions on replacement or repair of the devices.
Patients who have undergone procedures with recalled colonoscopes need not take action, as the risk applies to future use. Facilities should verify serial numbers against the recall list and coordinate with Olympus for device replacement.
The recalled product
- Product
- Colonoscope, Model Number PCF-H180AL.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 18
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 Number: PCF-H180AL
- UDI DI: 04953170339899
- Serial Number: 2005061
- 2007000
- 2108388
- 2108779
- 2109211
- 2109849
- 2200674
- 2201253
- 2301680
- 2800321
- 2801450
- 2801763
- 2802289
- 2903612
- 2903746
- 2903896
- 2904201
- 2904811
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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