MicroAire Surgical Instruments, LLC recalls Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic…
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Read the official notice →- Date
- 2025-06-18
- Country
- United States
- Brand
- MicroAire Surgical Instruments, LLC
- Product
- Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Denmark, United…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-06-25
USUmary-USA.com recalls UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
- US
Eugia US LLC recalls Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC,…
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
- US
Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC…
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- 2025-06-18
- US
BD SWITZERLAND SARL recalls BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may…
FDA · DeviceBD SWITZERLAND SARLWorldwide - US Nationwide distribution including in the states of MA, CA, IL,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
FDA · DeviceTurncare, IncUS Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…Official notice →