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

26651–26675 of 27722

HighFDA (Devices)·Z-1105-2013·2013-04-24
Siemens syngo WorkFlow SLR Recall for Patient Data Display Error
Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.
Product
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and…
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1114-2013·2013-04-24
Roche Recalls CoaguChek XS Pro Meters Due to Barcode Reading Errors
Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode patient identification barcodes.
Product
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2013·2013-04-24
ACIST Angiographic Injection System Recall for Air Ingress
Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.
Product
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1142-2013·2013-04-24
GE Healthcare Recalls Innova IQ Systems Due to Missing Safety Label
GE Healthcare is recalling 48 Innova IQ systems manufactured between March 2010 and July 2011 because a safety label is missing from the gantry pivot section.
Product
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1149-2013·2013-04-24
Maquet Cardiohelp Support System Recalled for Unexpected Shutdowns
Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.
Product
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1134-2013·2013-04-24
Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes
Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Product
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2013·2013-04-24
Edwards Lifesciences Recalls Duraflo Coated Femoral Cannula Due to Sealing Defect
Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.
Product
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2013·2013-04-24
Carefusion Recalls Alaris PC Unit 8015 Due to Bolus Programming Risk
Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.
Product
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2013·2013-04-24
Roche Recalls Accu-Chek Inform II Barcode Scanners Due to Decoding Errors
Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.
Product
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2013·2013-04-24
Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes
Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Product
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2013·2013-04-24
EndoGastric Solutions Recalls EsophyX2 Plus Devices Due to Lack of Validation
EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.
Product
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2013·2013-04-24
Philips IntelliSpace Portal Software Recall for URL PACS Integration Issue
Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.
Product
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2013·2013-04-24
Biomet Oxford Uni Knee System Toffee Hammer Recalled for Weld Cracking
Biomet U.K., Ltd. is recalling 430 Oxford Uni Knee System Toffee Hammers because excessive use may cause the head to detach from the handle.
Product
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1051-2013·2013-04-17
GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors
GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.
Product
Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1063-2013·2013-04-17
FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units
FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.
Product
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1066-2013·2013-04-17
Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled
Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.
Product
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1081-2013·2013-04-17
Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error
Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.
Product
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1058-2013·2013-04-17
Respironics Infant Masks Recalled Due to Incorrect Size Labeling
Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.
Product
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-1078-2013·2013-04-17
GE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk
GE Healthcare is recalling Infinia Nuclear Medicine Systems because a mechanical defect could cause the detector to slide, posing a risk to patients and operators.
Product
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2013·2013-04-17
J T Posey Recalls Biothane Restraint Cuffs Due to Tensile Strength Defect
J T Posey Company is voluntarily recalling 1,673 Biothane Restraint Cuffs because they failed to meet tensile strength specifications, posing a risk of disconnection.
Product
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2013·2013-04-17
Siemens Recalls Angiographic X-Ray Systems Due to Table Collision Risk
Siemens is recalling 51 angiographic x-ray systems because a malfunction in the table vertical lift could cause a collision if obstructed by a solid object.
Product
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2013·2013-04-17
Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.
Product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1082-2013·2013-04-17
Physio Control Recalls LIFEPAK Defibrillators Due to Battery Depletion Risk
Physio Control is recalling LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators because they may experience early internal battery depletion.
Product
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1085-2013·2013-04-17
Medtronic Recalls Paradigm Insulin Pumps Due to Cap Detachment Risk
Medtronic is recalling Paradigm insulin infusion pumps because a drive support cap may detach and allow water to damage internal electronics.
Product
Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2013·2013-04-17
Thermo Fisher CO2 Incubators Recalled for Hinge Failure
Thermo Fisher Scientific is recalling 15,567 CO2 incubators manufactured before mid-2009 because their coated metal hinges have reportedly failed in the field.
Product
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples.…
Category
Medical Device
Distribution
Distributed nationwide

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