Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 26241–26260 of 38,428 recalls
Recalled Item: Fluid Management Set. Catalog Number K08-MP5159A
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIA 27 Microcatheter
The Issue: Sequent Medical is recalling the VIA 27 Microcatheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V. Mueller Neuro/Spine
The Issue: risk associated with corrosion demonstrated on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC Brivo 715 Prime
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA Fusion 50 Ablation System
The Issue: Due to product design and process control, part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is
The Issue: There is a potential for a component failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:
The Issue: O-arm O2 Surgical Imaging System Spatial calibration may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD79b PE (ASR)
The Issue: CD79b (SN8) PE is contaminated with a FITC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe
The Issue: Sterility of syringe product could not be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empowr PS Knee System Box Cut Guide The EMPOWER PS
The Issue: It has been discovered that during Empowr PS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aequalis Fx2 implant parts and instrument trays. Insert component :
The Issue: Tornier is conducting a recall on Aequalis Fx2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PeroxiClear Peroxide Solution
The Issue: Product was found to contain excess residual levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empowr PS Knee System Box Cut Guide
The Issue: It has been discovered that during Empowr PS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or
The Issue: Issue with the process for detection of leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping...
The Issue: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping...
The Issue: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product...
The Issue: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision
The Issue: FDA inspection found that customers who had received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CT3Plus (a.k.a. CT3PZ)
The Issue: FDA inspection found that customers who had received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariaBreeze
The Issue: FDA inspection found that customers who had received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.