Uromedica Inc. recalls UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Read the official notice →- Date
- 2022-01-12
- Country
- United States
- Brand
- Uromedica Inc.
- Product
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-01-12
USAbbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- US
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
There is a potential for abnormal (non-sigmoidal) amplification curves.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Howmedica Osteonics Corp. recalls Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of…
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to…
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of GA, MI, NC, TX.Official notice → - US
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause…
FDA · DeviceDiaSorin Molecular LLCUS: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI,…Official notice → - US
Nikkiso Ltd - Shizuoka Plant recalls DBB-06 Hemodialysis Delivery System
Device lacks premarket approval.
FDA · DeviceNikkiso Ltd - Shizuoka PlantDistributed nationwide to NY, MO, WA, CA, and TN.Official notice → - US
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both…
FDA · DeviceQiagen Sciences LLCDomestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign…Official notice →