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

33601–33625 of 40325

ModerateFDA (Devices)·Z-1027-2015·2015-02-04
Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes
Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.
Product
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1010-2015·2015-02-04
Baxter Recalls Four Lead TUR Irrigation Sets Due to Seal Failure Risk
Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.
Product
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0955-2015·2015-02-04
GE Healthcare Recalls Revolution CT Scanners Due to Missing Quality Control Test
GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.
Product
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1032-2015·2015-02-04
Fresenius Kabi Recalls HEPFLUSH-10 Heparin Lock Flush Solution Due to pH Failure
Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.
Product
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1029-2015·2015-02-04
Orthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad
Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.
Product
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-1028-2015·2015-02-04
Smiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error
Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.
Product
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1030-2015·2015-02-04
Arrow Medical Kits Recalled for Incorrect Biopatch Dressing Size
Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Product
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0996-2015·2015-01-28
TransMotion Medical Recalls Powered Stretcher Chairs Due to Involuntary Movement
TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used in surgeries because the controllers may cause the chairs to move involuntarily.
Product
Powered stretcher chair used during facial and eye surgeries. One chair per package.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0993-2015·2015-01-28
Maquet Tegris System Recalled Due to Software Error in Operating Table Commands
Maquet Medical Systems USA is recalling six units of the Tegris System because a software error switches leg movement commands for the Magnus OR table.
Product
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2015·2015-01-28
Siemens Radiographic Systems Recalled for Potential Image Flipping Errors
Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.
Product
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1000-2015·2015-01-28
BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent
BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.
Product
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2015·2015-01-28
Cordis POWERFLEX PRO PTA Dilatation Catheter Recall for Unsterilized Unit
Cordis Corporation is recalling one unsterilized unit of the POWERFLEX PRO PTA Dilatation Catheter from a demonstration lot left at a hospital.
Product
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2015·2015-01-28
Ferno Model 35X Stretchers Recalled Due to Loose Wheel Assemblies
Ferno-Washington Inc is recalling 46 Model 35X stretchers because wheel castor assemblies may loosen, posing a risk of injury.
Product
Ferno Model 35X PROFlexx Stretchers, one unit per package
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0997-2015·2015-01-28
Philips IntelliVue TcG10 Monitor Recalled for Missing Contraindication Warning
Philips is recalling 86 IntelliVue TcG10 monitors because the instructions for use are missing a warning against using the device on patients under gas anesthesia.
Product
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1002-2015·2015-01-28
BD Biosciences Recalls Contaminated Anti-Lambda APC-H7 Antibody Lots
BD Biosciences is recalling two lots of Anti-Lambda APC-H7 antibody due to contamination with CD38 antibody. The product is used for in vitro flow cytometric immunophenotyping.
Product
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1007-2015·2015-01-28
Arrow Hemodialysis Catheterization Sets Recalled for Tunneling Sheath Cracking
Arrow International is recalling specific hemodialysis catheterization sets because the tunneling sheath can crack during placement, potentially delaying treatment.
Product
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0999-2015·2015-01-28
Roche Recalls cobas 4800 KRAS Mutation Test Kits for Invalid Results
Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.
Product
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1001-2015·2015-01-28
Genetic Testing Institute Recalls PF4 Concentrated Wash Reagent Lots
Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.
Product
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1005-2015·2015-01-28
Arrow International Recalls Multi-Lumen CVC Kits Due to Missing Instructions
Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.
Product
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1006-2015·2015-01-28
Aptalis Flutter Percussor Respiratory Device Recalled for Packaging Defect
Aptalis Pharmatech Inc. is recalling approximately 49,000 Flutter Percussor respiratory devices because the packaging may be difficult to open or close.
Product
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1004-2015·2015-01-28
Ortho-Clinical VITROS Software Recall Due to Calibration Failure
Ortho-Clinical Diagnostics is recalling VITROS Software Version 3.1 because calibration may not occur when using specific calibrator barcode labels.
Product
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative…
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0963-2015·2015-01-21
Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk
Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.
Product
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0916-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk
Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.
Product
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0980-2015·2015-01-21
Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks
Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.
Product
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0951-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete contact lenses because FDA testing found bacteria and the product is not sterile.
Product
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071…
Category
Medical Device
Distribution
3 states

How to read this listing

Filters

33601–33625 of 40325