Sol-Millennium Medical Inc. recalls Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2)…
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- Sol-Millennium Medical Inc.
- Product
- Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M…
- Classification
- Class II
- Units
- US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2024-09-18
USMEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW…
Potential for an incomplete seal on the packaging tray.
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11…
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL,…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number…
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
- US
Medtronic Neuromodulation recalls Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset…
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CRANIOTOMY PACK, Pack Number DYNJ46552O
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes…
- US
Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A…
Due to a manufacturing issue, red particulates present in the expressed composite.
FDA · DeviceUltradent Products, Inc.US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND,…Official notice →