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 17061–17080 of 38,428 recalls
Recalled Item: XP-XP Tibial Tray - Interlok 91mm Item # 195761
The Issue: The locking bar not fully engaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metalogix Slotted 90 Tubular Wrench x 10mm LOT A29618A
The Issue: Due to manufacturing processing error, wrench causing stripping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Conquest 40 PTA Dilation Catheter
The Issue: The catheter packaging incorrectly listed the balloon size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquilex Fluid Control System component: Bag deflector
The Issue: The deficit displayed by the pump can differ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998
The Issue: Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model
The Issue: Firm identified a subset of its generators that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product
The Issue: The product does not meet certain internal strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AssayTip/AssayCup Tray-used on the cobas e 801 module which is
The Issue: AssayTips part of the AssayTip/AssayCup Tray Tips used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product
The Issue: The product does not meet certain internal strength
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMED Oral Dispensers
The Issue: Exactamed 5 mL Oral Dispenser Pharmacy Packs may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZEUS ELISA Parvovirus B19 IgM Test System
The Issue: FDA inspection identified that due to increased positivity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian Multileaf Collimator [MLC]
The Issue: After a recent upgrade to the collimator software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Nexframe Stereotactic System and StealthStation Cranial software...
The Issue: Entry point and lead placement inaccuracies during deep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly
The Issue: Packages of abutments may contain an incorrect screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temporary Abutment Engaging CC RP pre-manufactured prosthetic components...
The Issue: Packages of abutments may contain an incorrect screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Base CC RP 1.5 mm
The Issue: Packages of abutments (universal base) may contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temporary Snap Abutment Engaging CC RP 1.5 mm
The Issue: Packages of abutments may contain an incorrect screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components...
The Issue: Packages of abutments may contain an incorrect screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snappy Abutment 5.5 CC RP 3 mm
The Issue: Packages of abutments may contain an incorrect screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct
The Issue: A QA inspection confirmed that a Healing Collar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.