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

5701–5725 of 13512

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
HighFDA (Devices)·Z-2432-2024·2024-07-31
Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life
Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.
Product
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2441-2024·2024-07-31
Sensis Vibe medical diagnostic system software crashes during documentation events
A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.
Product
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2435-2024·2024-07-31
Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility
B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.
Product
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2429-2024·2024-07-31
Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels
Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.
Product
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2434-2024·2024-07-31
Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility
B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.
Product
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2426-2024·2024-07-31
ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.
Product
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglob
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2024·2024-07-31
Sensis Vibe Cardiac Imaging System Software May Crash During Documentation
Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.
Product
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2415-2024·2024-07-31
Electrosurgical Generators Olympus ESG-410 May Fail to Power On
Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.
Product
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2445-2024·2024-07-31
LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings
LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.
Product
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2417-2024·2024-07-31
Call station devices may fail to transmit emergency alarms to staff
Securitas Healthcare's Arial Call Station (models CSK200 and CSK200MR) may fail to transmit alarms and experience premature battery depletion. The FDA recall affects 1,268 units distributed in the U.S. and Canada.
Product
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2423-2024·2024-07-31
Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component
Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.
Product
TourniKwik Tourniquet Set (CFN 79012)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2438-2024·2024-07-31
Sensis Vibe diagnostic systems software crash during event documentation
Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.
Product
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2436-2024·2024-07-31
Perfusor Space infusion pump syringe incompatibility may cause dosing error
B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.
Product
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2427-2024·2024-07-31
Medtronic A610 Clinician Programmer pocket adaptors limited to head-only MRI
Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.
Product
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descripti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2437-2024·2024-07-31
Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk
B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.
Product
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2433-2024·2024-07-31
Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose
B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.
Product
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2414-2024·2024-07-31
Dxl 9000 Immunoassay Analyzer Recalled for Corrosion of USB Cable Contacts
Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient test results.
Product
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2428-2024·2024-07-31
Beckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings
Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.
Product
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2418-2024·2024-07-31
Wireless Nurse Call Station Recalled for Potential Alarm Communication Failure
Arial Call Station wireless nurse call systems (models CSK200-1069 and CSK200-1069MR) are recalled due to risk of alarm communication failure and premature battery depletion. 77 units affected across multiple U.S. states.
Product
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2430-2024·2024-07-31
Abbott Infinity 5 Pulse Generator May Fail Prematurely
Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.
Product
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2424-2024·2024-07-31
BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution
Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.
Product
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2431-2024·2024-07-31
Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date
The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.
Product
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2425-2024·2024-07-31
Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.
Product
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2439-2024·2024-07-31
Medical device diagnostic software vulnerability causes potential application crashes
Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.
Product
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
Category
Medical Device
Distribution
Distributed nationwide

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5701–5725 of 13512