Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an… V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereCalifornia, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas and West Virginia
- Medical device recall Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic… V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereCalifornia, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas and West Virginia
- Medical device recall Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Smart Assist Set, EU A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Smart Assist Set, JP A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Pump Set, Japan A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Pump 371 Set, Clinical Trial A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Smart Assist Set, Canada A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pump 371 14F LT CMR Set A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Smart Assist Set APAC A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist Set, EU A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist Set, CA A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist Set, US A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pump 381 Pump Set (US) A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist S2 Set, US A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 SmartAssist Set, JP A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ImpellaCP SmartAssistSetAPAC, Delo1895 A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 Set AU A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella CP Smart Assist Set A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 SmartAssist S2 Set, JP A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist S2 Set, EU A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Power Express The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PE Centrifuge The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PE Centrifuge Temperature Controlled The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the… Class IIFDA’s classSep 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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