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 13666

HighFDA (Devices)·Z-0604-2024·2023-12-27
Abbott Hematology Analyzers Recalled for Unlabeled Latex Component
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
Product
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Category
Medical Device
Distribution
37 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-0578-2024·2023-12-27
Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
Product
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0570-2024·2023-12-27
Biomet Recalls Hip Implant Adapter Due to Wrong Specification in Packaging
Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.
Product
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0567-2024·2023-12-27
AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Product
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2024·2023-12-27
Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Product
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0609-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2024·2023-12-27
Injection Needle Recall Due to Cleaning Process Concerns
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.
Product
Injection Needle, REF: 25207
Category
Medical Device
Distribution
38 states
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
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-0585-2024·2023-12-27
Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Product
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Category
Medical Device
Distribution
16 states
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-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
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
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
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
HighFDA (Devices)·Z-0528-2024·2023-12-20
Sterile PVP Medical Solution Recalled for Non-Sterile Contents
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Product
STERILE PVP, REF DYNDA1649
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2024·2023-12-20
Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0519-2024·2023-12-20
Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
Product
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Category
Medical Device
Distribution
Distributed nationwide
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

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7701–7725 of 13666