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

23826–23850 of 27699

HighFDA (Devices)·Z-1103-2015·2015-02-18
Teleflex Medical Recalls AQUAPAK 640 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling AQUAPAK 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.
Product
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1109-2015·2015-02-18
Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.
Product
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2015·2015-02-18
Teleflex Medical Recalls Aquapak 101 SW Humidifier Adaptors for Foreign Material
Teleflex Medical is recalling Aquapak 101 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.
Product
AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2015·2015-02-18
Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material
Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.
Product
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2015·2015-02-18
SCC Soft Computer Recalls SoftPath Laboratory Information System Versions
SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System because diagnostic text modifications may not be saved or displayed correctly.
Product
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1062-2015·2015-02-18
Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect
Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.
Product
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1082-2015·2015-02-18
Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material
Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.
Product
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2015·2015-02-18
Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material
Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.
Product
AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2015·2015-02-18
Elekta Precise Digital Accelerator Recall for Potential Securing Bolt Failure
Elekta is recalling 46 Precise Digital Accelerators because securing bolts for the gantry counter frame weight stack may fail.
Product
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1059-2015·2015-02-11
Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission
Siemens Medical Solutions is recalling 310 LINAC Accelerators because the internal electric board may overheat, causing thermal damage and smoke emission.
Product
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1054-2015·2015-02-11
Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
Product
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1017-2015·2015-02-11
FDA Recalls Covidien Trellis-6 Peripheral Infusion Systems Due to Labeling Error
The FDA is recalling 216 units of the Covidien Trellis-6 Peripheral Infusion System because a manufacturing error caused the balloon inflation ports to be incorrectly labeled.
Product
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1034-2015·2015-02-11
Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.
Product
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1018-2015·2015-02-11
FDA Recalls Covidien Trellis-8 Peripheral Infusion Systems Due to Labeling Error
FDA is recalling 1,032 units of the Covidien Trellis-8 Peripheral Infusion System because a manufacturing error caused the proximal and distal balloon inflation ports to be incorrectly labeled.
Product
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2015·2015-02-11
Invacare Recalls G-Series Bed Rails Due to Entrapment Safety Defect
Invacare is recalling G-Series bed rails because the mounting bracket does not meet entrapment safety specifications.
Product
G- Series Beds; G29 full length bed rails assembly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2015·2015-02-11
Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture
Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.
Product
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2015·2015-02-11
SCC Soft Computer Recalls SoftLab Laboratory Information System Versions
SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.
Product
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2015·2015-02-11
Carl Zeiss Meditec FORUM Archive and Viewer Software Recall
Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.
Product
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2015·2015-02-11
Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces
Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.
Product
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1039-2015·2015-02-11
Baxter Integrated APD Set Recalled for Leakage Complaints
Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.
Product
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2015·2015-02-11
Sedecal MobileDiagnost wDR X-ray systems recalled for unexpected movement
Sedecal S.A. is recalling 283 MobileDiagnost wDR motorized portable diagnostic X-ray systems due to reports of unexpected movement.
Product
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2015·2015-02-11
Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors
Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.
Product
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1055-2015·2015-02-11
BD 10 mL Syringes Recalled Due to Improperly Seated Stopper
Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.
Product
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2015·2015-02-11
Zimmer Recalls Persona Tibial Articular Surface Provisional Shims Due to Cleaning Defect
Zimmer, Inc. is recalling Persona Tibial Articular Surface Provisional Shims because repeated sonic cleaning can break the ball bearing retention feature, potentially leaving parts in the surgical wound.
Product
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2015·2015-02-11
Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias
Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.
Product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Category
Medical Device
Distribution
Distributed nationwide

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23826–23850 of 27699