CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video recalled
Integrated Medical Systems is recalling Olympus, Model No. CF-H180AL, flexible scope, large diameter, video, distributed nationwide in the US. The recall was initiated on 20 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0891-2016
- FDA event ID
- 73088
- Recalling firm
- Integrated Medical Systems, Birmingham, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jan 2016
- FDA classified
- 25 Feb 2016
- Reported
- 2 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Jan 2016 | Recall initiated by company | |
| 25 Feb 2016 | Classified by FDA | +36 days |
| 2 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
Where it was distributed
Distributed US (nationwide) and in Australia.
Questions about this recall
Is Olympus, Model No. CF-H180AL, flexible scope, large diameter, video recalled?
Yes. Integrated Medical Systems recalled Olympus, Model No. CF-H180AL, flexible scope, large diameter, video on 20 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0891-2016.
Why was it recalled?
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Which lots are affected?
Serial Numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849, 2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559, 2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038, 2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580, 2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007, 2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009, 2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560, 2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106, 2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163, 2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263, 2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653, 2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241, 2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493, 2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544, 2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272, 2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750, 2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937, 2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343, 2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051, 2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017, 2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654, 2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046, 2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850, 2805888,2309542
Where was it sold?
Distributed US (nationwide) and in Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integrated Medical Systems
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus, Model No. Xcf-Q160ALE, flexible scope recalled | Integrated Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Olympus, Model No. Tjf-160F, flexible scope, large diameter, video recalled | Integrated Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Olympus, Model No. Gif-XP160, flexible scope, large diameter, video recalled | Integrated Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Olympus, Model No. Gif-160, flexible scope, large diameter, video recalled | Integrated Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Olympus, Model No. Gif-140, flexible scope, large diameter, video recalled | Integrated Medical Systems | Device Malfunction | Nationwide |
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