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…
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- Classification
- Class II
- Units
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 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…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Europe,…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 →US
Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Other drugs & medical recalls in the United States
- 2024-01-24
US
Cook Medical Llc recalls MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional…
FDA · DeviceCook Medical LlcDomestic distribution to CA IN LA MD NY International distribution to…Official notice →US
Sarnova HC, Llc recalls Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals…
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
US
Philips North America recalls Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG…
FDA · DevicePhilips North AmericaDomestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY…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…
US
Maquet Cardiovascular, LLC recalls Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →US
Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.