Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S,…
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to…
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Europe,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-02-14
USOlympus Corporation of the Americas recalls Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent…
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
FDA · DeviceOlympus Corporation of the AmericasDomestic US distribution nationwide.Official notice →- US
Olympus Corporation of the Americas recalls Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media…
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia.Official notice → - 2024-02-07
- US
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and…
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
FDA · DeviceOlympus Corporation of the AmericasNationwide. Foreign: AU BR BR CA DE HK IN JP SGOfficial notice → - 2024-01-24
- US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in…
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS…Official notice → - US
Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a…
- 2024-01-17
- US
Olympus Corporation of the Americas recalls Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source,…
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may…
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution.Official notice →
Other drugs & medical recalls in the United States
- 2024-01-24
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human…
- US
Xcision Medical Systems, LLC recalls GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in…
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
FDA · DeviceXcision Medical Systems, LLCWorldwide - US Nationwide distribution in the states of MD, PA, TX and the…Official notice → - US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…
Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the state of NH.Official notice → - US
Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during…
FDA · DeviceSmiths Medical Asd IncWorldwide distribution - US Nationwide and the countries of Canada, UAE.Official notice → - US
PHASE SCIENTIFIC INTERNATIONAL LIMITED recalls INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
FDA · DevicePHASE SCIENTIFIC INTERNATIONAL LIMITEDUS Nationwide distribution including in the states of CA, NY, VT, WA, OH, MD ,…Official notice → - US
Steris Corporation recalls V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through…
Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.