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

8451–8475 of 40007

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-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-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
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-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-0524-2024·2023-12-20
Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0546-2024·2023-12-20
Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Product
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2024·2023-12-20
Olympus tracheal intubation fiberscope recalled due to suction flow specification issue
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
Product
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
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-0534-2024·2023-12-20
Medline Leg Bags Recalled Due to Undeclared Latex
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Product
Medline Leg bag, REF DYND12578
Category
Medical Device
Distribution
0 states
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-0554-2024·2023-12-20
Sensica Urine Output System displays incorrect timestamps when connected to WiFi
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Product
Sensica Urine Output System, Catalog Number SCCS1002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2024·2023-12-20
Cardinal Health Stool Transportation System Recalled for Vial Leakage
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
Product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2024·2023-12-20
GE Definium Tempo X-Ray System Bolts May Loosen and Fall
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Product
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2024·2023-12-20
FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Product
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0551-2024·2023-12-20
Medical imaging software incorrectly displays patient studies to wrong patients
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
Product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Category
Medical Device
Distribution
Distributed nationwide
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-0530-2024·2023-12-20
Non-sterile Betadine solution labeled and distributed as sterile
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Product
STERILE BETADINE, REF DYNDA1998
Category
Medical Device
Distribution
Distributed nationwide
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-0533-2024·2023-12-20
FDA Recalls Medline Leg Bags for Undeclared Latex
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
Product
Medline Leg bag, REF DYND12574
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0550-2024·2023-12-20
Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
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

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8451–8475 of 40007