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 deaths or serious injuries are reported, 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

4526–4550 of 5038

SevereFDA (Devices)·Z-2159-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2021-2014·2014-07-30
Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing
Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.
Product
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn fr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2068-2014·2014-07-30
GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure
GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.
Product
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2046-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
Product
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2058-2014·2014-07-23
Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results
Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.
Product
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2023-2014·2014-07-16
Invacare Aquatec Fixed Backrest Recalled for Structural Failure Risk
Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.
Product
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1994-2014·2014-07-16
Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
Product
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1978-2014·2014-07-09
Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.
Product
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1985-2014·2014-07-09
Siemens Mobilett XP X-ray System Recalled for Fire Hazard
Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.
Product
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1991-2014·2014-07-09
Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.
Product
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1989-2014·2014-07-09
GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.
Product
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose dia
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1988-2014·2014-07-09
GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.
Product
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1959-2014·2014-07-09
Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk
Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1854-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1822-2014·2014-07-02
Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and inter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1925-2014·2014-07-02
Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1812-2014·2014-07-02
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydro
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1815-2014·2014-07-02
Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2014·2014-07-02
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2014·2014-06-18
Siemens Vista Air Compressor Recalled for Fire and Shock Hazards
Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.
Product
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnos
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1784-2014·2014-06-18
Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting
Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1715-2014·2014-06-11
Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation
Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.
Product
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1714-2014·2014-06-11
Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue
Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.
Product
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1719-2014·2014-06-11
ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning
ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.
Product
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Category
Medical Device
Distribution
Distributed nationwide

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