Stryker Instruments recalls Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical…
Read the official notice →- Date
- 2022-08-03
- Country
- United States
- Brand
- Stryker Instruments
- Product
- Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of Arizona,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-10
USTolmar, Inc. recalls Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC…
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- 2022-08-03
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide distribution in the states of Indiana and CA.Official notice → - US
Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental…
FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide and the countries of Australia, Chile,…Official notice → - US
MEDLINE INDUSTRIES, LP - SPT recalls Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…
Kits contain leaking bottles of isopropyl alcohol
- US
SIGHT DIAGNOSTICS LTD recalls Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice → - US
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
FDA · DeviceParagon 28, Inc.U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.Official notice →