BALT USA, LLC recalls The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal…
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of…
Read the official notice →- Date
- 2022-03-02
- Country
- United States
- Brand
- BALT
- Product
- The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal…
- Classification
- Class II
- Units
- Worldwide distribution - U.S. Nationwide distribution in the states of FL and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 BALT recalls
- 2025-11-05
USBALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100,…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
FDA · DeviceBALT USA, LLCUS distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and…Official notice →- 2025-06-25
- US
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694…
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
FDA · DeviceBALT USA, LLCWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2024-02-14
- US
BALT USA, LLC recalls Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under…
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the…
FDA · DeviceBALT USA, LLCU.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH,…Official notice → - 2022-10-26
- US
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product pouch label does not match up with carton label
FDA · DeviceBALT USA, LLCWorldwide distribution - U.S. Nationwide distribution in the states of FL, GA,…Official notice → - 2022-09-14
- US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Other drugs & medical recalls in the United States
- 2022-03-02
- US
Becton Dickinson & Company recalls BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port…
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
FDA · DeviceBecton Dickinson & CompanyUS Nationwide distribution in the state of IL.Official notice → - US
Stryker Sustainability Solutions recalls REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
- US
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling…
FDA · DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)Worldwide distribution - US Nationwide distribution in the states of FL, IL,…Official notice → - US
Nobel Biocare Usa Llc recalls NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could…
FDA · DeviceNobel Biocare Usa LlcWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Medtronic Vascular, Inc. recalls Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE;…
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a…
FDA · DeviceMedtronic Vascular, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Michels Transport Medium, 20ML Prefilled Cont
Product stored incorrectly in temperature controlled setting instead of refrigeration.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of Colorado, Florida, New York, North…Official notice →