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

901–925 of 5100

SevereFDA (Devices)·Z-2603-2024·2024-09-04
Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
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-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
CriticalFDA (Devices)·Z-2636-2024·2024-08-28
McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion
McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.
Product
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2587-2024·2024-08-28
ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism
Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.
Product
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2637-2024·2024-08-28
McGRATH MAC EMS Video Laryngoscope Battery Management System Recall
Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.
Product
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2543-2024·2024-08-21
RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure
Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.
Product
RMU-2000 Automated Chest Compression Device
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-2449-2024·2024-08-21
Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss
ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.
Product
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2448-2024·2024-08-21
Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect
ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.
Product
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2447-2024·2024-08-21
Plum 360 Infusion Battery Recall Due to Manufacturing Defect
ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.
Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2446-2024·2024-08-14
Puritan Bennett 500 Series Ventilators recalled due to volatile organic compound release
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
Product
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilat
Category
Medical Device
Distribution
34 states
CriticalFDA (Devices)·Z-2442-2024·2024-08-14
Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
Product
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2420-2024·2024-08-14
CADD-Solis VIP Ambulatory Infusion Pump Class I Recall
Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.
Product
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of in
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2443-2024·2024-08-14
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2419-2024·2024-08-14
CADD-Solis Ambulatory Infusion Pumps with Software Defects Affecting Device Responsiveness
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
Product
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that re
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2444-2024·2024-08-14
Medline Procedure Kits Recalled Due to Defective Syringes and Quality Issues
Medline procedure kits containing defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.
Product
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ5
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2421-2024·2024-08-14
Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
Product
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies t
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2409-2024·2024-07-31
NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk
Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.
Product
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2319-2024·2024-07-24
Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection
Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.
Product
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2321-2024·2024-07-24
Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter
Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.
Product
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2322-2024·2024-07-24
Volara System Blue Ventilator Adapter Module Handset Plug Disconnection
Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.
Product
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2252-2024·2024-07-17
Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2251-2024·2024-07-17
Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.
Product
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2253-2024·2024-07-17
BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
Product
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2313-2024·2024-07-17
Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk
Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.
Product
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Category
Medical Device
Distribution
0 states

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901–925 of 5100