FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma ext…
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M1…
View FDA Recall →Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from …
View FDA Recall →AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part…
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Li…
View FDA Recall →AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, P…
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Li…
View FDA Recall →Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness).
View FDA Recall →FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage relat…
View FDA Recall →FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car…
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA cathe…
View FDA Recall →ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm …
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…
View FDA Recall →Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or lea…
View FDA Recall →Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
View FDA Recall →