Straight Smile, LLC recalls BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically…
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Straight Smile, LLC
- Product
- BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of CO, KS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-01
USMEDLINE INDUSTRIES, LP - Northfield recalls ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- US
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the…
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONU.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.Official notice → - US
Becton, Dickinson and Company, BD Bio Sciences recalls FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended…
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric…
FDA · DeviceBecton, Dickinson and Company, BD Bio SciencesWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - US
Limacorporate S.p.A recalls TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
- US
3M Company - Health Care Business recalls Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833…
Attachments may not mate with the tooth as intended in the digital treatment design.
FDA · Device3M Company - Health Care BusinessProduct was distributed nationwide US, and internationally to Canada,…Official notice →