Class IIOngoingZ-2461-2025
Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC P…
Due to out of the box wobble of the driver.
Medtronic Xomed, Inc.FLSep 3, 2025
Recalls in Florida
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 55 recalls
Class IIIOngoingZ-2451-2025
Bausch & Lomb Surgical, Inc. recalls Akreos
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acui…
Bausch & Lomb Surgical…FLSep 3, 2025
Class IIOngoingZ-2239-2025
Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Philips Medical System…FLAug 13, 2025
Class IIOngoingZ-2163-2025
Johnson & Johnson Vision Care, Inc. recalls ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Due to defects (bubbles/voids) identified during standard finished goods testing
Johnson & Johnson Visi…FLJul 30, 2025
Class IIOngoingZ-1859-2025
Ultra Clean Systems, Inc. recalls Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number…
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Ultra Clean Systems, I…FLJun 4, 2025
Class IOngoingZ-1680-2025
Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Bausch & Lomb Surgical…FLMay 14, 2025
Class IOngoingZ-1679-2025
Bausch & Lomb Surgical, Inc. recalls Intraocular lens. enVista Monofocal IOL
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Bausch & Lomb Surgical…FLMay 14, 2025
Class IIOngoingZ-1623-2025
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Medtronic Xomed, Inc.FLApr 30, 2025
Class IIOngoingZ-1511-2025
Cordis US Corp recalls Cordis
product mix-up; Vascular stent labeled as one size but contains a different size.
Cordis US CorpFLApr 9, 2025
Class IIOngoingZ-1510-2025
Cordis US Corp recalls Cordis
product mix-up; Vascular stent labeled as one size but contains a different size.
Cordis US CorpFLApr 9, 2025
Class IIOngoingZ-1330-2025
Cordis US Corp recalls Vista Brite Tip
Catheter manufactured at the incorrect length.
Cordis US CorpFLMar 19, 2025
Class IIOngoingZ-1294-2025
TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS)
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to i…
TAS Medical IncFLMar 12, 2025