Drugs & medicalClass II

Invacare Corporation recalls DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE…

Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

Read the official notice →
Date
2023-08-30
Country
United States
Brand
Invacare
Product
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE…
Classification
Class II
Units
US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Invacare recalls

  1. 2024-03-13
  2. US
    Drugs & medicalClass II

    Invacare Corporation recalls Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5)…

    Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

    FDA · DeviceInvacare CorporationUS Nationwide distribution.Official notice →
  3. 2022-07-20
  4. US
    Drugs & medicalClass III

    Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

    Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

    FDA · DeviceInvacare CorporationDomestic distribution to the following states: ALASKA ARIZONA CALIFORNIA…Official notice →
  5. 2022-06-01
  6. US
    Drugs & medicalClass II

    Invacare Corporation recalls Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The…

    FDA · DeviceInvacare CorporationWorldwide distribution - US Nationwide distribution in the states of AK, AR,…Official notice →
  7. 2022-01-12
  8. US
    Drugs & medicalClass II

    Invacare Corporation recalls Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R,…

    Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile,…

    FDA · DeviceInvacare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice →
All 5 Invacare recalls →

Other drugs & medical recalls in the United States

  1. 2023-08-30
  2. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement…

    As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The…

    FDA · DeviceRandox Laboratories Ltd.CA, FL, IL, ME, MI, NC, OH, PA,NJ,Official notice →
  3. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC…

    The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride,…

    (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in…

    FDA · DeviceRandox Laboratories Ltd.Worldwide distribution - US Nationwide distribution in the states of AR, FL,…Official notice →
  5. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

    A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE…

    FDA · DeviceSmith & Nephew, Inc.US, AE, CA, DE, ES, GB, MX, PA, PLOfficial notice →
  6. US
    Drugs & medicalClass II

    Boston Scientific Corporation recalls EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

    There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

    FDA · DeviceBoston Scientific CorporationWorldwideOfficial notice →
  7. US
    Drugs & medicalClass II

    BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    Due to manufacturing issue, panels may result in false negative results.

    FDA · DeviceBioFire Diagnostics, LLCUS: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV…Official notice →
See all drugs & medical recalls →