Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive
Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.
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: FDA Class II medical device recall involving a structural manufacturing defect (missing protective adhesive) that could cause device failure if exposed to vibration, temperature fluctuation, or shock loads. No illnesses or injuries reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 36 repaired colonoscopes, Model Number CF-H180AL, distributed nationwide.
These units were assembled without an adhesive that protects the device from physical stress conditions including high levels of vibration, temperature fluctuation, or severe shock loads. Without this protective adhesive, the colonoscope may not function properly if exposed to these conditions.
Thirty-six units with specific serial numbers are affected by this recall. Patients and healthcare facilities should verify whether their equipment matches one of the recalled serial numbers. Healthcare providers using these devices should contact Olympus Corporation of the Americas for repair or replacement instructions.
The recalled product
- Product
- Colonoscope, Model Number CF-H180AL.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Colonoscope
- Affected units
- 36
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: CF-H180AL
- UDI DI: 4953170339608
- Serial Number: 2001426
- 2001524
- 2001614
- 2002139
- 2002212
- 2002285
- 2103817
- 2104137
- 2104581
- 2105255
- 2105976
- 2107112
- 2207880
- 2207929
- 2207940
- 2309317
- 2601078
- 2601096
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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