Compass Health Brands (Corporate Office) recalls Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager…
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Read the official notice →- Date
- 2022-01-26
- Country
- United States
- Brand
- Compass Health Brands
- Product
- Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt…
- Classification
- Class II
- Units
- Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Compass Health Brands recalls
- 2023-04-26
USCompass Health Brands (Corporate Office) recalls REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle…
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
FDA · DeviceCompass Health Brands (Corporate Office)Worldwide distribution - US Nationwide and the country of Canada.Official notice →- 2021-12-22
- US
Compass Health Brands Recalls Carex Adult Portable Bed Rails After Three Deaths; Entrapment and Asphyxiation Hazards
When attached to an adult's bed, users can become entrapped within the bed rail or between the rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
Other drugs & medical recalls in the United States
- 2022-01-26
- US
Covidien, LP recalls SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable…
FDA · DeviceCovidien, LPThe devices were distributed to the following US states: CA, CO, FL, IL, KY,…Official notice → - US
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm…
FDA · DeviceStraumann USA LLCUS Nationwide Distribution in the states of FL, IL, OHOfficial notice → - US
Microbiologics Inc recalls KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC…
Contamination with S. epidermidis
FDA · DeviceMicrobiologics IncDistribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and…Official notice → - US
Philips North America Llc recalls Infa-Therm Transport Mattress, Reference Number 989805616831 1015
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new…
- US
Gentueri Inc recalls Gentueri Viral Transport Medium (VTM), Sterile, IVD
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →