Agency classClass IIOur severity:High FDA (Devices)·Z-1211-2024·Announced 2024-03-06

Colonoscope Model PCF-H190L Recalled for Missing Protective Adhesive

Olympus Corporation recalled 31 colonoscopes lacking a protective adhesive that shields against vibration, temperature fluctuations, and shock. The missing adhesive may affect device structural integrity under physical stress.

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 recall of a medical device with a structural defect (missing protective adhesive). Although no injuries or illnesses have been reported, the defect creates a risk-of-harm situation where device malfunction is possible under physical stress conditions.

Plain-English summary

Olympus Corporation of the Americas recalled 31 Colonoscope Model PCF-H190L units distributed nationwide. The affected units are specific repaired colonoscopes that were assembled without a protective adhesive designed to shield the device from physical stress.

The missing adhesive normally protects against high levels of vibration, temperature fluctuations, and severe shock loads. Without it, the colonoscopes may not maintain their intended structural integrity or function reliably under these conditions.

Affected medical facilities should verify whether they received any of the 31 units with the affected serial numbers and contact Olympus Corporation of the Americas for further instructions.

The recalled product

Product: Colonoscope, Model Number PCF-H190L.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopy
Hazard: structural-defect
malfunction-risk
Affected units: 31

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-H190L
UDI DI: 04953170305191
Serial Number: 2201678
2201735
2301759
2301775
2301929
2301930
2302159
2302280
2302281
2302380
2302506
2303832
2303927
2404124
2404132
2404806
2404888
2404967

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.

See all 10 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

See all →

Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · structural defect