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323 reported ongoing
327 records in this archive. Latest source date Aug 18, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Class IIIReported ongoing
Distribution: Natiowide Foreign: Canada, Germany
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Class IIIReported ongoing
Distribution: Natiowide Foreign: Canada, Germany
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Class IIReported ongoing
Distribution: US Nationwide Distribution
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troublesho...
Class IIReported ongoing
Distribution: FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
Class IIReported ongoing
Distribution: US Nationwide domestic distribution.
Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with t...
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution to Canada and Japan.
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Class IIReported ongoing
Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Class IIReported ongoing
Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Class IIReported ongoing
Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, NM.
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Class IIReported terminated
Distribution: Nationwide distribution in the US. Foreign distribution worldwide.
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal p...
Class IIReported terminated
Distribution: US Nationwide distribution in the state of KY.
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, FL, NC, NY.
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases pe...
Class IIReported ongoing
Distribution: CA FL MA MD MI NJ OH PR WI
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases pe...
Class IIReported ongoing
Distribution: CA FL MA MD MI NJ OH PR WI
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases pe...
Class IIReported ongoing
Distribution: CA FL MA MD MI NJ OH PR WI
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Class IIReported terminated
Distribution: US Nationwide Distribution
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of AZ.
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Class IIReported ongoing
Distribution: Nationwide
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.