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

26326–26350 of 27722

HighFDA (Devices)·Z-1740-2013·2013-07-24
Stryker TPS Universal Driver Recalled for Unintended Activation Risk
Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.
Product
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1729-2013·2013-07-24
KooJoo Trading Company Recalls Unsterilized Safety Lancets
KooJoo Trading Company is recalling specific lots of Odyssey safety lancets because they were not sterilized within the established validation dose range.
Product
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1749-2013·2013-07-24
Edwards Lifesciences Recalls Suction Wands Due to Plastic Particulate
Edwards Lifesciences is recalling specific models of rigid suction wands because plastic particulate was found inside the sterile pouch and within the wand.
Product
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1741-2013·2013-07-24
Stryker CORE Universal Driver Recalled for Unintended Activation Risk
Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.
Product
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2013·2013-07-24
Siemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect
Siemens is recalling 23 AXIOM Artis zee/zeego angiographic x-ray systems because a tolerance problem in the generator power supply may cause the generator to fail.
Product
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1751-2013·2013-07-24
Hospira Recalls Symbiq IV Pump Sets Due to Air-in-Line Alarm Risk
Hospira is recalling Symbiq IV pump sets because a defective ball valve may fail to seal, causing air-in-line alarms during fluid administration.
Product
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies
Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.
Product
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2013·2013-07-24
Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims
Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.
Product
B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error
Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2013·2013-07-24
Stryker RemB Electric Universal Driver Recalled for Unintended Activation
Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.
Product
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1699-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1668-2013·2013-07-17
Medtronic MiniMed Paradigm Insulin Infusion Sets Recalled for Malfunction Risk
Medtronic MiniMed is recalling Paradigm insulin infusion sets because they may malfunction and deliver incorrect insulin volumes if exposed to fluids.
Product
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1667-2013·2013-07-17
Bryan Medical Recalls Mislabeled Pediatric Tracheostomy Tubes
Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm pediatric tracheostomy tubes because they were mislabeled as smaller infant tubes.
Product
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1685-2013·2013-07-17
Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.
Product
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1693-2013·2013-07-17
Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material
Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.
Product
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1669-2013·2013-07-17
Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking
Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.
Product
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1698-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 30 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1711-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 37 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone to impinge on the bearing.
Product
REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1696-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1702-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1707-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement in terminal extension.
Product
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1677-2013·2013-07-17
Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection
Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection after storage.
Product
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1709-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Implants
Biomet is recalling 20 Oxford Fixed Bearing Partial Knee implants due to a design defect that may cause anterior impingement between bone and the poly bearing component.
Product
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1704-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement during full knee extension.
Product
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
Category
Medical Device
Distribution
4 states

How to read this listing

Filters

26326–26350 of 27722