Johnson & Johnson Surgical Vision, Inc. recalls THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac…
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation…
Read the official notice →- Date
- 2022-11-09
- Country
- United States
- Brand
- Johnson & Johnson Surgical Vision
- Product
- THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Johnson & Johnson Surgical Vision recalls
- 2023-08-09
USJohnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.International distribution to the countries of China, India, Korea.Official notice →- US
Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of NC, OH, NY,…Official notice → - 2023-02-01
- US
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France,…Official notice → - 2022-10-19
- US
Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL…Official notice → - 2022-05-11
- US
Johnson & Johnson Surgical Vision Inc recalls TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Potential breach in the sterility barrier for tray ring covers.
FDA · DeviceJohnson & Johnson Surgical Vision IncWorlwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2021-10-13
- US
Johnson & Johnson Surgical Vision Inc recalls TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS…
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit.…
FDA · DeviceJohnson & Johnson Surgical Vision IncU.S. Nationwide distribution in the state of IL.Official notice →
Other drugs & medical recalls in the United States
- 2022-11-09
- US
Becton Dickinson Infusion Therapy Systems Inc. recalls BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
FDA · DeviceBecton Dickinson Infusion Therapy Systems Inc.U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode…Official notice → - US
Becton, Dickinson and Company, BD Biosciences recalls BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD…
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
FDA · DeviceBecton, Dickinson and Company, BD BiosciencesU.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,…Official notice → - US
MICROVENTION INC. recalls WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may…
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL,…Official notice → - US
Rebiscan, Inc. recalls Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using…
Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly…
FDA · DeviceRebiscan, Inc.Worldwide distribution - US Nationwide and the countries of New Zealand,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.Official notice → - US
Belmont Instrument Corporation recalls CritiCool, thermoregulation device
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the…
FDA · DeviceBelmont Instrument CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice →