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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Olympus Corporation of the Americas: Specific Repaired Colonoscopes Recalled for Lack of Protective Adhesive

Agency Publication Date: February 29, 2024
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Summary

Olympus Corporation of the Americas is recalling 265 specific colonovideoscopes that were repaired and returned to customers without a necessary protective adhesive. These medical devices, including models like the CF-H180AL, CF-HQ190L, and PCF-H190DL, are used by healthcare professionals for internal colon examinations. The missing adhesive was intended to protect the internal components of the scopes from physical stress during use and transport. Olympus is initiating this voluntary recall to ensure the devices are properly re-assembled with the required adhesive to prevent potential equipment failure.

Risk

Without the protective adhesive, the internal components of the colonoscopes are vulnerable to damage from high vibration, temperature fluctuations, or physical shocks. This can lead to device malfunction or failure during a medical procedure, which could potentially result in injury to the patient or a delay in treatment.

What You Should Do

  1. Identify if your facility possesses any of the affected colonoscopes by checking the model and serial numbers. The recall includes: Model CF-H180AL (Serial Nos: 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); Model CF-HQ190I (Serial No: 2263354); Model CF-HQ190L (Serial Nos: 2082724 through 2982143); Model CF-Q180AL (Serial Nos: 2602060, 2603763); Model PCF-H180AL (Serial Nos: 2005061 through 2904811); Model PCF-H190DL (Serial Nos: 2046148 through 2945260); Model PCF-H190L (Serial Nos: 2201678 through 2628544); Model PCF-H190TL (Serial No: 2110150); Model PCF-HQ190L (Serial Nos: 2000569 through 2308226); and Model PCF-Q180AL (Serial Nos: 2200140, 2603268, 2808983, 2909332).
  2. Healthcare providers should contact Olympus Corporation of the Americas directly for instructions regarding the inspection or return of these specific repaired units.
  3. If you are a patient scheduled for a procedure involving an Olympus colonoscope, you may contact your healthcare provider to discuss any concerns regarding the equipment being used.
  4. For further assistance or to report issues, contact Olympus Corporation of the Americas at their Center Valley, PA headquarters at 3500 Corporate Pkwy, Center Valley, PA 18034.
  5. Contact the FDA for additional questions or to report adverse events at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact Olympus Corporation of the Americas

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Colonoscope, Model Number CF-H180AL
Model / REF:
CF-H180AL
UPC Codes:
4953170339608
Lot Numbers:
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
Product: Colonoscope, Model Number CF-HQ190I
Model / REF:
CF-HQ190I
UPC Codes:
4953170305139
Lot Numbers:
2263354
Product: Colonoscope, Model Number CF-HQ190L
Model / REF:
CF-HQ190L
UPC Codes:
04953170305115
Lot Numbers (97):
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
Product: Colonoscope, Model Number CF-Q180AL
Model / REF:
CF-Q180AL
UPC Codes:
04953170307706
Lot Numbers:
2602060
2603763
Product: Colonoscope, Model Number PCF-H180AL
Model / REF:
PCF-H180AL
UPC Codes:
04953170339899
Lot Numbers:
2005061
2007000
2108388
2108779
2109211
2109849
2200674
2201253
2301680
2800321
2801450
2801763
2802289
2903612
2903746
2903896
2904201
2904811
Product: Colonoscope, Model Number PCF-H190DL
Model / REF:
PCF-H190DL
UPC Codes:
04953170363672
Lot Numbers:
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
Product: Colonoscope, Model Number PCF-H190L
Model / REF:
PCF-H190L
UPC Codes:
04953170305191
Lot Numbers:
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
Product: Colonoscope, Model Number PCF-H190TL
Model / REF:
PCF-H190TL
UPC Codes:
04953170420702
Lot Numbers:
2110150
Product: Colonoscope, Model Number PCF-HQ190L
Model / REF:
PCF-HQ190L
UPC Codes:
4953170416118
Lot Numbers:
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
Product: Colonoscope, Model Number PCF-Q180AL
Model / REF:
PCF-Q180AL
UPC Codes:
4953170307720
Lot Numbers:
2200140
2603268
2808983
2909332

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93832
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 10 products (36; 1; 97; 2; 18; 47; 31; 1; 28; 4)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.