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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93832

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 11, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Colonoscope, Model Number CF-H180AL.

Z-1205-2024
Recall number
Z-1205-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
36

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

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, 2601255, 2601368, 2601700, 2702380, 2702460, 2702478, 2702805, 2703697, 2704366, 2704490, 2806996, 2807975, 2900004, 2900185, 2900249, 2908770, 2909110, 2909884;

Distribution pattern

US Nationwide distribution.

device · product 2 of 10

Colonoscope, Model Number CF-HQ190I.

Z-1206-2024
Recall number
Z-1206-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: CF-HQ190I; UDI DI: 4953170305139; Serial Number: 2263354;

Distribution pattern

US Nationwide distribution.

device · product 3 of 10

Colonoscope, Model Number CF-HQ190L.

Z-1207-2024
Recall number
Z-1207-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
97

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: CF-HQ190L; UDI DI: 04953170305115; Serial Number: 2082724, 2082896, 2082936, 2083461, 2083765, 2084560, 2085050, 2186261, 2187110, 2187274, 2187811, 2188037, 2188206, 2200530, 2201625, 2201677, 2201844, 2202345, 2288483, 2288940, 2289129, 2289391, 2289421, 2289572, 2290978, 2291472, 2303312, 2304024, 2304070, 2314598, 2315390, 2391750, 2391772, 2391857, 2392281, 2417328, 2417450, 2417702, 2417736, 2417755, 2418202, 2418754, 2418843, 2419006, 2419007, 2419105, 2510489, 2510795, 2510801, 2511164, 2512292, 2512458, 2512470, 2512569, 2512817, 2513285, 2524619, 2524916, 2625144, 2635605, 2635832, 2636020, 2636500, 2636782, 2637892, 2659060, 2659357, 2759754, 2761671, 2762243, 2772492, 2773247, 2773259, 2773324, 2773552, 2874236, 2875490, 2875615, 2875616, 2875656, 2876636, 2876811, 2876877, 2877237, 2877319, 2877901, 2978291, 2978331, 2978640, 2979287, 2979510, 2980281, 2980304, 2980541, 2981322, 2982038, 2982143;

Distribution pattern

US Nationwide distribution.

device · product 4 of 10

Colonoscope, Model Number CF-Q180AL.

Z-1208-2024
Recall number
Z-1208-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: CF-Q180AL; UDI DI: 04953170307706; Serial Number: 2602060, 2603763;

Distribution pattern

US Nationwide distribution.

device · product 5 of 10

Colonoscope, Model Number PCF-H180AL.

Z-1209-2024
Recall number
Z-1209-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

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 pattern

US Nationwide distribution.

device · product 6 of 10

Colonoscope, Model Number PCF-H190DL.

Z-1210-2024
Recall number
Z-1210-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
47

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: PCF-H190DL; UDI DI: 04953170363672; Serial Number: 2046148, 2046377, 2500549, 2501714, 2602501, 2602549, 2602675, 2602884, 2603086, 2605185, 2605189, 2605279, 2605338, 2605343, 2615621, 2716237, 2716306, 2716379, 2727123, 2727529, 2737897, 2738603, 2839269, 2839284, 2839580, 2840038, 2840130, 2840639, 2840669, 2840719, 2840798, 2840928, 2842302, 2942674, 2942814, 2943131, 2943193, 2943240, 2943296, 2943451, 2943708, 2943820, 2944426, 2944690, 2944765, 2944939, 2945260;

Distribution pattern

US Nationwide distribution.

device · product 7 of 10

Colonoscope, Model Number PCF-H190L.

Z-1211-2024
Recall number
Z-1211-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
31

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

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, 2405012, 2405253, 2405290, 2405353, 2517013, 2517120, 2517422, 2517440, 2517541, 2517616, 2517649, 2517705, 2628544;

Distribution pattern

US Nationwide distribution.

device · product 8 of 10

Colonoscope, Model Number PCF-H190TL.

Z-1212-2024
Recall number
Z-1212-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: PCF-H190TL; UDI DI: 04953170420702; Serial Number: 2110150;

Distribution pattern

US Nationwide distribution.

device · product 9 of 10

Colonoscope, Model Number PCF-HQ190L.

Z-1213-2024
Recall number
Z-1213-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200, 2307709, 2307713, 2308226;

Distribution pattern

US Nationwide distribution.

device · product 10 of 10

Colonoscope, Model Number PCF-Q180AL.

Z-1214-2024
Recall number
Z-1214-2024
Initiated
January 11, 2024
Classification
Class II
Status
Ongoing
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Code information

Model Number: PCF-Q180AL; UDI DI: 4953170307720; Serial Number: 2200140, 2603268, 2808983, 2909332;

Distribution pattern

US Nationwide distribution.