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

25176–25200 of 27722

HighFDA (Devices)·Z-1506-2014·2014-04-30
Teleflex Recalls Sengstaken Tubes Due to Sterility Concerns
Teleflex Medical is recalling Sengstaken and Sengstaken-Blakemore tubes because the sterility of the product cannot be guaranteed.
Product
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2014·2014-04-30
BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results
BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue caused false negative results in Rapid ID 32 strips and API biochemical tests.
Product
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1454-2014·2014-04-23
FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1461-2014·2014-04-23
Philips CT Scanners Recalled for Defective Service Latch Component
Philips Medical Systems is recalling 135 CT scanners because a defective service latch component can cause the patient table top to become free-floating.
Product
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1453-2014·2014-04-23
Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
Ev3 Neurovascular is recalling 32 Pipeline Embolization Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1460-2014·2014-04-23
Siemens AXIOM Vertix MD Trauma Systems Recalled for U-Arm Drop Risk
Siemens is recalling two AXIOM Vertix MD Trauma systems because defective steel ropes may cause the U-arm to drop unexpectedly, posing a risk of serious injury to patients.
Product
AXIOM Vertix MD Trauma systems radiographic X-ray
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1442-2014·2014-04-23
SpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure
Del Mar Reynolds Medical is recalling 16 SpaceLabs Arkon Anesthesia Delivery Systems with Version 2.0 software because they may enter a controlled failed state.
Product
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2014·2014-04-23
Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation
Edwards Lifesciences is recalling 28,885 Fem-Flex II Arterial and Femoral Cannulae because the dilator tips may separate.
Product
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2014·2014-04-23
GE OEC 9900 Elite Mobile Fluoroscopy System Recall for Monitor Fall Risk
GE Healthcare is recalling 453 OEC 9900 Elite mobile fluoroscopy systems because defective screws may cause the workstation monitor to fall forward.
Product
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1459-2014·2014-04-23
CareFusion SmartSite Extension Set Recalled for Tubing Disconnections and Leaks
CareFusion 303, Inc. is recalling 7,700 SmartSite Extension Sets due to disconnections and leakages at the tubing and Y-port connection.
Product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2014·2014-04-23
Gambro Cartridge Blood Sets Recalled Due to Occluded Heparin Tubing
Gambro Renal Products is recalling specific Gambro Cartridge Blood Sets because occluded heparin tubing may prevent anticoagulation dosing during hemodialysis.
Product
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2014·2014-04-23
Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect
Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.
Product
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1466-2014·2014-04-23
Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation
Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.
Product
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1458-2014·2014-04-23
Biomet 3i Recalls Dental Implants Due to Residual Machining Fluid
Biomet 3i is recalling 34,744 endosseous dental implants because residual machining fluid was identified on the external surface.
Product
BIOMET 3i Endosseous Dental Implant.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1448-2014·2014-04-16
Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect
Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.
Product
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1440-2014·2014-04-16
Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault
Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.
Product
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.
Product
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1432-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1418-2014·2014-04-16
Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise
Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Product
10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1425-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1419-2014·2014-04-16
Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.
Product
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1445-2014·2014-04-16
Alcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect
Alcon LenSx is recalling 75 ophthalmic lasers used in cataract surgery due to reports of unexpected downward motion of the gantry.
Product
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1424-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1433-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.
Product
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1421-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.
Product
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Category
Medical Device
Distribution
35 states

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