15+ device recalls in 2025

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Here are 17 medical device and technology recalls, as reported by Becker’s so far in 2025:

Note: This list is not exhaustive.

  1. Abiomed issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers.
  2. Olympus Corp. recalled its ViziShot 2 FLEX needles manufactured prior to May 12 after reports of the device components detaching during procedures.
  3. The FDA issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries. 
  4. Boston Scientific issued a recall of its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that could cause resistance during device withdrawal. 
  5. Draeger recalled its SafeStar and TwinStar breathing system filters due to a risk of misleading carbon dioxide readings. 
  6. Dexcom recalled 19 models of its continuous glucose monitoring receivers due to a speaker malfunction that could prevent alerts for dangerous blood sugar levels. 
  7. Medline expanded a correction involving procedure kits containing its Medtronic aortic root cannulas, due to risk of serious injury or death. 
  8. Smiths Medical issued a Class I recall for certain CADD-Solis and CADD-Solis VIP ambulatory infusion pumps due to multiple issues that could interrupt or delay medication delivery. 
  9. BD and its subsidiary C.R. Bard issued a Class I recall for several esophagogastric balloon tamponade tubes because of difficulties in removing plastic plugs from the device’s rubber lumens. 
  10. Abbott issued a recall for select HeartMate mobile power units used with its HeartMate3 and HeartMate III left-ventricular assist systems due to risk of sudden power loss that could lead to serious injury or death. 
  11. Medtronic issued a recall for several aortic root cannula devices due to a potential safety risk that could cause loose material to dislodge during use, potentially leading to stroke or death.
  12. Smiths Medical recalled certain sizes of its Portex oral/nasal endotracheal tubes because of a manufacturing defect that results in a smaller diameter, which could potentially lead to inadequate ventilation. 
  13. Medtronic recalled certain Pipeline Vantage Embolization Devices with Shield Technology due to an increased risk of incomplete wall apposition and braid deformation, which could lead to stroke or death.
  14. Baxter Healthcare issued a recall for some Spectrum infusion pumps due to a potential defect involving missing motor mounting screws, which could lead to interruptions, delays or incorrect dosing of medication. 
  15. Johnson & Johnson MedTech issued a recall for its Biosense Webster Varipulse Bi-Directional Ablation Catheter following reports of strokes and transient ischemic attacks in patients undergoing procedures with the device. 
  16. Boston Scientific recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. 
  17. Abiomed, also known as Johnson & Johnson MedTech, issued a recall for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps due to safety concerns. 
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