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

38651–38675 of 40449

LowFDA (Devices)·Z-1125-2013·2013-04-24
Instrumentation Industries Recalls Manual Jet Ventilators for Updated Directions
Instrumentation Industries is recalling specific manual jet ventilators and accessories to replace previously distributed Directions for Use with updated versions.
Product
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet…
Category
Medical Device
Distribution
44 states
LowFDA (Devices)·Z-1148-2013·2013-04-24
Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk
Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.
Product
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the…
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
HighFDA (Devices)·Z-1077-2013·2013-04-17
Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk
Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.
Product
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1061-2013·2013-04-17
Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment
Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.
Product
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2013·2013-04-17
GE Healthcare Recalls LOGIQ Ultrasound Systems Due to Potential Skin Burn Risk
GE Healthcare is recalling LOGIQ S8 and S7 ultrasound systems equipped with the S4-10-D probe due to a potential safety issue that may cause skin burns.
Product
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1100-2013·2013-04-17
GE Healthcare Recalls Discovery MR750w Systems Due to Image Flip Defect
GE Healthcare is recalling 46 Discovery MR750w 3.0T MRI systems worldwide due to a potential image flip issue that may result in incorrect anatomical localization.
Product
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2013·2013-04-17
Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 188 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 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1072-2013·2013-04-17
Elekta Precise Treatment Table Recalled for Column Rotation Defect
Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.
Product
Precise Treatment Table. To be used as part of radiation therapy treatment process.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2013·2013-04-17
GE Healthcare Recalls VMX Mobile X-ray Units Due to Arm Base Casting Issue
GE Healthcare is recalling VMX and VMX Plus mobile X-ray units because a defect in the arm base casting may impact operator or patient safety.
Product
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2013·2013-04-17
Synthes Flexible Grip Recalled for Cleaning Limitations
Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.
Product
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1076-2013·2013-04-17
Kerr Maxcem Elite Resin Cement Recalled for Premature Polymerization
Kerr Corporation is recalling Kerr Maxcem Elite resin cement kits and syringes because raw material causes the product to set prematurely, potentially preventing proper restoration placement.
Product
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1068-2013·2013-04-17
Toshiba CT System Recalled for Software Error in Low-Current Scans
Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.
Product
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1084-2013·2013-04-17
Ormco Recalls Bracket Buccal Tubes Due to Packaging Error
Ormco is voluntarily recalling one lot of Bracket Buccal Tubes because the packaging incorrectly identifies the product offset, which may cause unintended tooth rotation.
Product
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Category
Medical Device
Distribution
Distributed nationwide

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38651–38675 of 40449