Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy…
Read the official notice →- Date
- 2021-12-29
- Country
- United States
- Brand
- Acclarent
- Product
- TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Classification
- Class II
- Units
- US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Acclarent recalls
- 2023-11-01
USAcclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and…
FDA · DeviceAcclarent, Inc.US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME,…Official notice →
Other drugs & medical recalls in the United States
- 2022-01-05
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Teligent Pharma, Inc. recalls Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent…
Superpotent Drug
FDA · DrugTeligent Pharma, Inc.Distributed to a wholesaler in CO who further distributed Nationwide in the USAOfficial notice → - 2021-12-29
- US
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A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy…
FDA · DeviceMedtronic Navigation, Inc.US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT,…Official notice → - US
Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging…
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the states of DC, GA,…Official notice → - US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice → - US
Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some…
FDA · DeviceLeica Microsystems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, DC,…Official notice →