Olympus Corporation of the Americas recalls EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus,…
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
Read the official notice →- Date
- 2023-02-22
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Olympus Corporation of the Americas recalls
- 2023-05-31
USOlympus Corporation of the Americas recalls ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle…
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.
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Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code:…
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that…
- 2023-04-26
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Olympus Corporation of the Americas recalls Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model…
There have been complaints that the clip did not come out of the tube sheath during the procedure.
- 2023-02-15
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Olympus Corporation of the Americas recalls SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
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…
FDA · DeviceOlympus Corporation of the AmericasFL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VAOfficial notice → - 2022-12-14
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Olympus Corporation of the Americas recalls HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
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.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide domestic distribution.Official notice → - 2022-10-19
- US
Olympus Corporation of the Americas recalls Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
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…
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Foreign distribution to Canada and Japan.Official notice →
Other drugs & medical recalls in the United States
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Advantice Health, Llc recalls Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75…
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
FDA · DrugAdvantice Health, LlcProduct was distributed via the internet, distributors and retailers nationwide.Official notice → - 2023-02-22
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Siemens Medical Solutions USA, Inc. recalls SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R…
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Conformis, Inc. recalls iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
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FDA · DeviceConformis, Inc.US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA,…Official notice → - US
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
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OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17
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