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…
Read the official notice →- Date
- 2023-05-31
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
- Classification
- Class II
- Units
- US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-07-26
USOlympus Corporation of the Americas recalls Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- 2023-06-28
- US
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog…
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The…
- 2023-05-31
- US
Olympus 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.
- 2023-04-26
- US
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.
- 2023-02-22
- US
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
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.Official notice → - 2023-02-15
- US
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 →
Other drugs & medical recalls in the United States
- 2023-05-31
- US
OmniCell, Inc. recalls Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
- US
Olympus 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.
- US
Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay,…
- US
SD Biosensor, Inc. recalls Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
- US
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max (VE10, VF10, VF11)
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point,…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide DistributionOfficial notice → - US