Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct…
Read the official notice →- Date
- 2025-08-20
- Country
- United States
- Brand
- Diversatek Healthcare
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Classification
- Class III
- Units
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Diversatek Healthcare recalls
- 2026-04-29
US
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
FDA · DeviceDiversatek HealthcareUS: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ,…Official notice →- 2023-09-13
US
Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
FDA · DeviceDiversatek Healthcareworldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY,…Official notice →- 2022-09-28
US
Diversatek Healthcare recalls Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps,…
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
Other drugs & medical recalls in the United States
- 2025-08-27
US
Haleon US Holdings LLC recalls Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ…
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
US
US
- 2025-08-20
US
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls; Part Number: 0020300200;
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL…
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Algeria, Andorra, Argentina,…Official notice →US
Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy,…Official notice →US
CareFusion 303, Inc. recalls Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS…
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH,…Official notice →