Olympus Corporation of the Americas recalls SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
- Classification
- Class II
- Units
- Domestic: OUS Only; International distribution in the states of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-05-29
USOlympus Corporation of the Americas recalls InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid…
Potential for distal end of the sheath to break off during a procedure.
FDA · DeviceOlympus Corporation of the AmericasDomestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.Official notice →- 2024-05-08
- US
Olympus Corporation of the Americas recalls POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.Official notice → - 2024-04-17
- US
Olympus Corporation of the Americas recalls Hemostasis Probe, Model: CD-B622LA
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- 2024-04-03
- US
Olympus Corporation of the Americas recalls Insufflation unit, UHI-4.
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
- US
Olympus Corporation of the Americas recalls InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model…
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be…
FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice → - 2024-03-06
- US
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Other drugs & medical recalls in the United States
- 2024-04-03
- US
Boston Scientific Corporation recalls Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Canada.Official notice → - US
Applied Medical Resources Corp recalls Epix Universal Clip Applier, REF: CA500, STERILEEO
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
FDA · DeviceApplied Medical Resources CorpWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Philips North America recalls CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- US
Bolton Medical Inc. recalls RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part…
The stent-graft inside the delivery system was the incorrect size.
FDA · DeviceBolton Medical Inc.Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The…Official notice → - US
DeRoyal Industries Inc recalls GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- US
Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice →