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.

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6076–6100 of 39968

  • HighFDA (Devices)·Z-2980-2024·2024-09-11

    Beckman Power Express Centrifuge Sample Holder May Detach During Operation

    An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.

    Product
    PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2024·2024-09-11

    Impella 5.5 Pump Labeling Updated Due to Device Interaction

    Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.

    Product
    Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2951-2024·2024-09-11

    Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose

    Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.

    Product
    Isoflurane E_Vap.(Safety Filling adapter): 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: Part Number 115-066758-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2964-2024·2024-09-11

    Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk

    Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.

    Product
    Pump 381 Pump Set (US); Product Code: 1000080;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2965-2024·2024-09-11

    Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction

    Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2948-2024·2024-09-11

    BD Pyxis QFill Medication Cabinet Software Bug Causes Incorrect Restock Labels

    The BD Pyxis QFill Replenishment Station medication cabinet has a software issue that may print incorrect bin information on restock labels for medications stored in non-CUBIE locations.

    Product
    BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2024·2024-09-11

    Power Express PE Centrifuge adhesive joint failure may cause component detachment

    The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.

    Product
    PE Centrifuge, REF: B36365, a component of the Power Express
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2024·2024-09-11

    Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction

    Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.

    Product
    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2024·2024-09-11

    Medical Device Sample Holder Recalled for Adhesive Joint Failure

    Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing lab staff to biohazardous material.

    Product
    Power Express, REF B90918
    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-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-2959-2024·2024-09-11

    Abiomed Impella Pump Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 43,636 Impella Pumps to update instructions for use regarding a potential interaction with Shockwave Coronary IVL Catheters.

    Product
    Pump 371 14F LT CMR Set; Product Code: 0048-0045;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2963-2024·2024-09-11

    Abiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 2,916 Impella 5.5 units to update labeling regarding a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
    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-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-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-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
  • 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
  • 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
  • CriticalFDA (Devices)·Z-2611-2024·2024-09-04

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect

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

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45;
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • SevereFDA (Devices)·Z-2604-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Manufacturing Defect in Securement Flange

    Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to a manufacturing defect that may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , P
    Category
    Medical Device
    Distribution
    0 states