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

34651–34675 of 40325

ModerateFDA (Devices)·Z-2735-2014·2014-10-08
Nanosphere Verigene BC-GP Kit Extraction Tray Recall
Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.
Product
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2716-2014·2014-10-08
Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.
Product
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0010-2015·2014-10-08
GE Healthcare Precision 500D X-ray Systems Recalled for Missing Screws
GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.
Product
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2722-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2732-2014·2014-10-08
Apollo Endosurgery Recalls LAP-BAND AP Systems Distributed Past Expiration
Apollo Endosurgery is recalling 10 LAP-BAND AP Systems distributed past their expiration date in seven states.
Product
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2721-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 65 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2726-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2719-2014·2014-10-08
St. Jude Medical Percutaneous Trial Lead Kit Manual Recall
St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.
Product
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2717-2014·2014-10-08
KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift
KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.
Product
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2712-2014·2014-10-08
Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect
Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.
Product
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general…
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-2715-2014·2014-10-08
Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.
Product
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2718-2014·2014-10-08
St. Jude Medical Percutaneous Trial Lead Kit Manual Recall
St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.
Product
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2621-2014·2014-10-01
ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.
Product
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2685-2014·2014-10-01
Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors
Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.
Product
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from…
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-2620-2014·2014-10-01
ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk
ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.
Product
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2702-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2014·2014-10-01
ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.
Product
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2593-2014·2014-10-01
CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk
CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.
Product
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2014·2014-10-01
ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate
ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.
Product
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2707-2014·2014-10-01
Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode
Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.
Product
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2695-2014·2014-10-01
PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk
PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.
Product
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2698-2014·2014-10-01
Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking
Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during attachment or manipulation.
Product
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2675-2014·2014-10-01
Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting
Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.
Product
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2678-2014·2014-10-01
Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction
Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.
Product
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2703-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm is recalling 22,042 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in…
Category
Medical Device
Distribution
Distributed nationwide

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34651–34675 of 40325