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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

6026–6050 of 39844

HighFDA (Devices)·Z-2946-2024·2024-09-11
W L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects
W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *Fo
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-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-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
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-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-2958-2024·2024-09-11
Impella CP Smart Assist Set device interaction with coronary catheters
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
Product
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Category
Medical Device
Distribution
Distributed nationwide
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
8 states
HighFDA (Devices)·Z-2947-2024·2024-09-11
BD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
Product
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2970-2024·2024-09-11
Impella 5.5 SmartAssist S2 Labeling Updated for Shockwave Catheter Interaction
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Product
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2024·2024-09-11
Beckman Coulter DxI 9000 Analyzer Recalled for Leaking Wash Buffer Tank
Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2956-2024·2024-09-11
Impella CP Pump Set Recalled for Potential Device Interaction
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
Product
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Category
Medical Device
Distribution
Distributed nationwide
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-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-2945-2024·2024-09-11
Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
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-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-2968-2024·2024-09-11
Abiomed Recalls Impella 5.5 Sets Due to Potential Shockwave Catheter Interaction
Abiomed is recalling 20 Impella 5.5 Set AU units because there is no labeling information regarding a potential interaction with Shockwave Coronary IVL Catheters.
Product
Impella 5.5 Set AU; Product Code: 1000361;
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-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-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-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

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