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

5726–5750 of 40007

SevereFDA (Devices)·Z-3153-2024·2024-10-02
Ivenix Infusion Pump Software Recalled for Potential Malfunctions
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3292-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.
Product
AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3135-2024·2024-10-02
CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
Product
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3134-2024·2024-10-02
Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk
Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.
Product
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3289-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.
Product
AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3137-2024·2024-10-02
CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
Product
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3091-2024·2024-10-02
Smiths Medical Recalls paraPAC 300 Ventilator Kits Due to Connector Issue
Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.
Product
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3249-2024·2024-10-02
IntelliVue Patient Monitors recalled for electrical grounding defect
Philips is recalling approximately 545 IntelliVue Patient Monitor units with a broken ground bolt that may cause loss of electrical grounding, potentially affecting the device's electromagnetic immunity and emission.
Product
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3081-2024·2024-10-02
GE Panda iRES infant warmer electrical safety testing incomplete
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
Product
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-010
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3213-2024·2024-10-02
Cervical disc implant recalled due to foreign contamination during assembly
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3245-2024·2024-10-02
FDA Recalls Surgical Instrument Handle That May Break During Use
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3136-2024·2024-10-02
Cardiac Support Device Software Defect Risks Hemodynamic Instability
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
Product
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3237-2024·2024-10-02
Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Product
Hand Pack, AKHD97C; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3228-2024·2024-10-02
Endovascular AAA Pack recalled for sterilization assurance failure
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Product
Endovascular AAA Pack, ESED52B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3290-2024·2024-10-02
Esophageal stent systems recalled due to delivery catheter defect
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Product
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3238-2024·2024-10-02
Vaginal Delivery Medical Convenience Kit Recalled for Unconfirmed Sterilization Assurance
American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.
Product
Vaginal Delivery, ASDV25B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3283-2024·2024-10-02
Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3266-2024·2024-10-02
WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Product
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2024·2024-10-02
WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
Product
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3275-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3259-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3296-2024·2024-10-02
Origio Sperm Wash Medium Recalled Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.
Product
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3244-2024·2024-10-02
Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Product
Pacemaker, COPM11B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide

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5726–5750 of 40007