Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog…
Due to manufacturing issues reperfusion catheters may fracture.
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- Penumbra
- Product
- Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Penumbra recalls
- 2026-07-29
US
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
FDA · DevicePenumbra, Inc.Worldwide - US Nationwide distribution including in the states and territories…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-07
US
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the…
FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN,…Official notice →US
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…
Due to incorrect inside packaging label for eyepiece.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of AZ, CA and MO.Official notice →US
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965…
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA,…Official notice →US
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version…
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous…
US
Olympus Corporation of the Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE…
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the country of Poland.Official notice →US
SPECTRUM MEDICAL SRL recalls Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W…
Due to blood-to-glycol leak in the heat exchanger.
FDA · DeviceSPECTRUM MEDICAL SRLUS Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC,…Official notice →