Olympus Corporation of the Americas recalls EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus,…
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…
Read the official notice →- Date
- 2022-06-29
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, FL, NC, NY.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-10-05
US
Olympus Corporation of the Americas recalls Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device…
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
FDA · DeviceOlympus Corporation of the AmericasNationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREAOfficial notice →- 2022-08-17
US
Olympus Corporation of the Americas recalls ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
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…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of AL, NM.Official notice →- 2022-07-06
US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
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.
FDA · DeviceOlympus Corporation of the AmericasNationwide distribution in the US. Foreign distribution worldwide.Official notice →- 2022-06-29
US
Olympus Corporation of the Americas recalls Colonovideoscope Model CF-H180AL
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…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the state of KY.Official notice →- 2022-06-22
US
Olympus Corporation of the Americas recalls Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
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…
- 2022-06-01
US
Olympus Corporation of the Americas recalls Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Other drugs & medical recalls in the United States
- 2022-06-29
US
Beaver Visitec International, Inc. recalls BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency…
Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250
FDA · DeviceBeaver Visitec International, Inc.US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA,…Official notice →US
New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product…
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being…
FDA · DeviceGetinge Usa Sales IncUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri,…Official notice →US
Olympus Corporation of the Americas recalls Colonovideoscope Model CF-H180AL
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…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the state of KY.Official notice →US
Bard Peripheral Vascular Inc recalls REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag,…
FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of MS, NC,…Official notice →US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306,…
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) -…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution. US nationwide including US Virgin Islands, Countries…Official notice →