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

6076–6100 of 40007

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
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-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-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-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-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-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-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-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-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
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
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
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-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-2605-2024·2024-09-04
Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure
Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2692-2024·2024-09-04
FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.
Product
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-2608-2024·2024-09-04
Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear Risk
Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL
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-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-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

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6076–6100 of 40007