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

7701–7725 of 13652

HighFDA (Devices)·Z-0608-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0575-2024·2023-12-27
Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy
Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.
Product
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0610-2024·2023-12-27
LITe Decompression Snake Arm cannot attach due to incorrect clamp component
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
Product
LITe Decompression Snake Arm, REF 48080230
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0579-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for vacuum loss in bags
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Product
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0601-2024·2023-12-27
Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Product
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2024·2023-12-27
Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0560-2024·2023-12-27
Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
Product
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0603-2024·2023-12-27
ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
Product
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0568-2024·2023-12-27
ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling
Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.
Product
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0595-2024·2023-12-27
CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numb
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2024·2023-12-27
Vero Biotech GENOSYL DS cassette recalled for manufacturing flow defect
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
Product
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0586-2024·2023-12-27
Exactech knee replacement inserts recalled for vacuum seal loss
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Product
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0602-2024·2023-12-27
ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Product
ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0505-2024·2023-12-20
Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure
Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.
Product
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-0548-2024·2023-12-20
CereLink ICP Extension Cable Recalled for Out of Range Readings
Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.
Product
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2024·2023-12-20
Medline PVP Solution Recalled Due to Mislabeled Sterility
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
Product
PVP SOLUTION SING STRL, REF DYNDA1858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2024·2023-12-20
Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2024·2023-12-20
Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2024·2023-12-20
Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Product
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2024·2023-12-20
Povidone Solution Labeled Sterile Despite Non-Sterile Contents
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Product
STERILE POVIDONE, REF DYNDA2061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2024·2023-12-20
Medical Device Recall: Medline Leg Bag with Undeclared Latex
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Product
Medline Leg bag, REF URO12573
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0522-2024·2023-12-20
SynchroMed Model A10 Infusion Pump Software Display Error
Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.
Product
Medtronic SynchroMed, Model A10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0517-2024·2023-12-20
Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
Product
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0543-2024·2023-12-20
Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
Product
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2024·2023-12-20
Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Product
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wri
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

7701–7725 of 13652