Contract Medical International GmbH recalls Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594…
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Read the official notice →- Date
- 2025-09-17
- Country
- United States
- Brand
- Contract Medical International GmbH
- Product
- Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-09-17
USWaldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the…Official notice →- US
CORNEAT VISION, LTD. recalls CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
FDA · DeviceCORNEAT VISION, LTD.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL,…Official notice → - US
Boston Scientific Corporation recalls Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material…
- US
AVID Medical, Inc. recalls Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Potential for open header bag seals, compromising sterility.
- US
Siemens Medical Solutions USA, Inc recalls Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Limited system movements after startup .
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A,…Official notice → - US
B.Braun Medical S.A.S. recalls Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product…
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.