Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill…
Read the official notice →- Date
- 2024-07-10
- Country
- United States
- Brand
- Angiodynamics
- Product
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Angiodynamics recalls
- 2025-03-26
USAngiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Official notice →- 2025-01-08
- US
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL,…Official notice → - 2024-08-07
- US
Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
- 2024-05-15
- US
- US
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- 2024-03-27
- US
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the…
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-17
- US
SYNCHRONICITY SPA INC, DBA SUNTE recalls suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity…
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
FDA · DrugSYNCHRONICITY SPA INC, DBA SUNTEDistributed Nationwide in the USA and Queensland, Christchurch, Ontario,…Official notice → - US
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- 2024-07-10
- US
Stryker Sustainability Solutions recalls Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA · DeviceStryker Sustainability SolutionsInternational distribution to the country of Japan.Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS…
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the…Official notice → - US
Abbott Medical recalls Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of…
FDA · DeviceAbbott MedicalUS: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found…