Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE…
Reports of various packaging issues that may result in a breach of the sterile barrier.
Read the official notice →- Date
- 2025-01-22
- Country
- United States
- Brand
- Sklar Instruments
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE…
- Classification
- Class II
- Units
- Domestic: Nationwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-22
US
A L I Technologies Ltd recalls Change Healthcare Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
FDA · DeviceA L I Technologies LtdUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →US
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…
FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, LA and the country…Official notice →US
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of IN, TN & TX.Official notice →US
Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →US
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High)…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of New Jersey and the…Official notice →US
SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the…
FDA · DeviceSIN SISTEMA DE IMPLANTE NACIONAL S.AUS distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND…Official notice →