The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

5226–5250 of 13512

  • HighFDA (Devices)·Z-2949-2024·2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    Product
    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2953-2024·2024-09-11

    Philips Azurion 7M20 Fluoroscopic X-Ray System FlexArm Movement Recall

    Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.

    Product
    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2024·2024-09-11

    Abiomed updates Impella CP labeling for Shockwave coronary catheter interaction

    Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.

    Product
    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2954-2024·2024-09-11

    Impella CP Smart Assist Set: Device interaction safety labeling update

    Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.

    Product
    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2961-2024·2024-09-11

    Impella 5.5 with SmartAssist Set: Potential Device Interaction During Coronary Interventions

    Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.

    Product
    Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2024·2024-09-11

    Impella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction

    Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.

    Product
    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2024·2024-09-11

    Impella 5.5 Cardiac Pump Labeling Updated for Device Interaction Risk

    Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.

    Product
    Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2024·2024-09-11

    Impella CP Smart Assist Set Recalled for Device Interaction Labeling Update

    Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.

    Product
    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2024·2024-09-11

    Impella CP Smart Assist Set: Potential Device Interaction with Coronary Catheter

    Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.

    Product
    Impella CP Smart Assist Set; Product Code: 1000402;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2960-2024·2024-09-11

    Impella CP Cardiac Assist Pump Lacks Shockwave Catheter Interaction Warning

    Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.

    Product
    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2606-2024·2024-09-04

    Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2590-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2612-2024·2024-09-04

    Tracheostomy Tubes Recalled for Possible Flange Tearing Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona pediatric and neonatal tracheostomy tubes because the securement flange may tear due to a manufacturing defect. The recall affects multiple tube sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2599-2024·2024-09-04

    Tracheostomy Tubes Recalled Due to Securement Flange Tears

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2598-2024·2024-09-04

    Tracheostomy Tube Flange May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. This affects pediatric and adult sizes distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2597-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear Due to Manufacturing Defect

    Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2600-2024·2024-09-04

    Tracheostomy Tube Recall: PORTEX Bivona Due to Manufacturing Defect in Securement Flange

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2602-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUB
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2024·2024-09-04

    Bivona Neonatal Tracheostomy Tubes recalled due to defective securement flanges

    Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2615-2024·2024-09-04

    PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRAC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2595-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Securement Flange Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , P
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2609-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes May Tear Due to Manufacturing Defect

    Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2589-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2601-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. The defect affects multiple lot numbers across all size variants distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM
    Category
    Medical Device
    Distribution
    0 states