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 34241–34260 of 38,428 recalls
Recalled Item: Integrity. Version 1.1 of the Integrity interface and control software
The Issue: During the treatment table, gantry, and collimator calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT Desktop The EOS RT Desktop
The Issue: During the treatment table, gantry, and collimator calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agility. Version 3.1 of the Integrity interface and control software
The Issue: During the treatment table, gantry, and collimator calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergy XVI The Elekta Synergy S is intended to be
The Issue: collision risk when using XVI and external
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergy XVI XVI can incorrectly calculate the target position of
The Issue: XVI can incorrectly calculate the target position of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XiO RTP System. Used to create treatment plans for any
The Issue: When bolus is present, the Effective Depth (with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Port Kit with Access Infusion Set under the following labels:
The Issue: Navilyst Medical has recalled a Port Kit with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XiO RTP System The XiO RTP System is used to
The Issue: When the number of fractions is changed for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR 7500 with FF WS These products are permanently installed
The Issue: Carestream Health Inc. has issued a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX-Evolution with CSH WS These products are permanently installed diagnostic
The Issue: Carestream Health Inc. has issued a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX-Evolution with FF WS These products are permanently installed diagnostic
The Issue: Carestream Health Inc. has issued a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HT Connect Peripheral Guide Wire Part Number Description 1012587 018
The Issue: Abbott Vascular has initiated a recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (R)
The Issue: One batch of the Reflection(TM) Polyethylene Acetabular Liners
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viscocel and Viscocel Plus. These products are intraocular fluid devices
The Issue: CLR Medicals International Inc., initiated a nationwide recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic
The Issue: This issue is only relevant for customers importing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Abbott m2000sp is an automated system for performing sample
The Issue: The x-drive assembly may fail prematurely. This could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4042LH: 3 mL Line Draw
The Issue: issue with the plunger tip of the Portex¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4042-2: 3 mL Line Draw
The Issue: issue with the plunger tip of the Portex¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G1777: Umbilical (2) 3 mL Line Draw
The Issue: issue with the plunger tip of the Portex¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G2001: 3 mL Line Draw
The Issue: issue with the plunger tip of the Portex¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.