FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
View FDA Recall →GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORE…
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of…
View FDA Recall →Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect pati…
View FDA Recall →Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
View FDA Recall →SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality…
View FDA Recall →Papablic Replacement Brush Heads. Model Number: Papablic18B
Potential for brush heads to break.
View FDA Recall →EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass…
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, …
View FDA Recall →MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled,…
View FDA Recall →FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car…
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
View FDA Recall →ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introd…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manu…
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