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 the agency’s own highest classification or reported deaths or serious injuries, 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

38676–38700 of 40449

ModerateFDA (Devices)·Z-1099-2013·2013-04-17
US Endoscopy Recalls Torrent Irrigation Tubing Due to Water Leakage
US Endoscopy Group Inc is recalling Torrent irrigation tubing because customers reported water leakage from the white tubing connector.
Product
Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1067-2013·2013-04-17
Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error
Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.
Product
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1070-2013·2013-04-17
AGFA IMPAX CV Software Recall for Incorrect Data Transfer
AGFA Corp. is recalling 26 units of IMPAX CV software because baseline pulmonary capillary wedge pressure values were not correctly transferring into hospital electronic health records.
Product
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1069-2013·2013-04-17
AGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error
AGFA Corp. is recalling IMPAX CV 7.8 SU3 software due to a design error. The product was distributed in Florida and Kentucky.
Product
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1101-2013·2013-04-17
Toshiba MRI Systems Recalled for LCD Monitor Backlight Failure
Toshiba American Medical Systems is recalling 27 Titan X and Titan 3T MRI systems because the console LCD monitor backlight may turn off during use.
Product
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1073-2013·2013-04-17
Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity
Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.
Product
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1092-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling First Aid Type IV Belt Type kits because the iodine ampule labels incorrectly imply the entire package is sterile.
Product
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1075-2013·2013-04-17
Tosoh G7 HPLC Analyzer Recalled for Beta-Thalassemia Detection Failure
Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.
Product
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1088-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling
Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits because the iodine ampule labels incorrectly imply the entire package is sterile.
Product
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1093-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits With Misleading Sterility Labels
Lighthouse For The Blind is recalling 425 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.
Product
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1087-2013·2013-04-17
Lighthouse For The Blind Recalls Antiseptic Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 2,815 antiseptic kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.
Product
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1089-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 1,034 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.
Product
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1091-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling
Lighthouse For The Blind is recalling 227 First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.
Product
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1086-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling
Lighthouse For The Blind is recalling 635 Type I First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.
Product
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1090-2013·2013-04-17
Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error
Lighthouse For The Blind is recalling 41,595 First Aid Type III kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.
Product
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1045-2013·2013-04-10
Zimmer NexPosure Retractor Portals Recalled for Sterility Risk
Zimmer, Inc. is recalling 58 NexPosure retractor portals due to a potential breach in the sterile inner pouch, which could lead to product contamination and patient infection.
Product
Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0993-2013·2013-04-10
Animas 2020 Insulin Pump Recall for False Alarm Component Issue
Animas Corporation is recalling 7,157 Animas 2020 insulin pumps due to a component issue that may cause false alarms for loss of prime, occlusion, or no cartridge detected.
Product
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1014-2013·2013-04-10
Smiths Medical Recalls BCI Remote Alarm Cables for Capnograph Systems
Smiths Medical is recalling 39 BCI Remote Alarm Cables because they may fail to transfer alarm signals to remote nurse alarm systems.
Product
Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2013·2013-04-10
LeMaitre Stent Guide Recalled Due to Compromised Sterility
LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.
Product
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2013·2013-04-10
Horiba Medical Recalls ABX Micros IM2 Data Management System
Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Product
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1033-2013·2013-04-10
Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking erroneous test results.
Product
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2013·2013-04-10
Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks
Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.
Product
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1043-2013·2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1030-2013·2013-04-10
Integra Ojemann Cortical Stimulator Recalled for Potential Electrical Injury Risk
Integra Burlington MA, Inc. is recalling 371 Ojemann Cortical Stimulators because a non-intended voltage could be transmitted to patients during surgery.
Product
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
Category
Medical Device
Distribution
Distributed nationwide

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38676–38700 of 40449