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

31151–31175 of 40325

SevereFDA (Devices)·Z-0586-2016·2016-01-20
Thornhill Research Recalls MOVES Emergency Ventilators Due to Battery Defects
Thornhill Research Inc. is recalling 83 MOVES System emergency ventilators because the batteries may become unresponsive after storage and remain perpetually enabled.
Product
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0641-2016·2016-01-20
Ortho-Clinical VITROS 5600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.
Product
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2016·2016-01-20
CompView NuCARTGN Medical Display Recall Due to Spring Arm Detachment Risk
CompView Medical is recalling 10 NuCARTGN mobile display units because the spring arm may detach if the securing ring was not installed correctly.
Product
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0625-2016·2016-01-20
Zimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect
Zimmer Biomet is recalling the Virage OCT Spinal Fixation System because set screw staking is out of specification, which can interfere with rod insertion.
Product
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0622-2016·2016-01-20
OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.
Product
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative…
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0648-2016·2016-01-20
Brainlab RT Elements software recall for image cropping defect
Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.
Product
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2016·2016-01-20
Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0626-2016·2016-01-20
Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.
Product
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0624-2016·2016-01-20
Nipro Medical Recalls Hemodialysis Blood Tubing Sets Due to Foaming
Nipro Medical Corporation is recalling 1,484 disposable hemodialysis blood tubing sets because blood foaming was found during product evaluation.
Product
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0652-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.
Product
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm endoscopes with specific instruments.
Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2016·2016-01-20
Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0627-2016·2016-01-20
Bayer Recalls Medrad Source Administration Sets for Dosing Errors
Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.
Product
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2016·2016-01-20
Mercury Medical Recalls Neo-Tee T-Piece Resuscitators Due to Occlusion Risk
Mercury Medical is recalling Neo-Tee T-Piece Resuscitators and circuits because incorrect use can cause complete circuit occlusion, leading to failure to ventilate the patient.
Product
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2016·2016-01-20
Skytron Ergon 2 Monitor Brackets Recalled Due to Hardware Failure Risk
Skytron is recalling 286 Ergon 2 monitor brackets because hardware may fail, causing displays to fall and potentially injure patients or providers.
Product
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment…
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0642-2016·2016-01-20
Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0623-2016·2016-01-20
ArthroCare Cavity 8 Gauge Spine Wand Recalled for Sterile Barrier Failure
ArthroCare Corporation is recalling 262 Cavity 8 Gauge Spine Wands because cracking in the tray compromises the sterile barrier.
Product
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label
Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and produce erroneous results.
Product
Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0646-2016·2016-01-20
Zimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws
Zimmer Biomet is recalling 400 units of Periarticular Locking Plate System screws because the package labels did not match the product contents.
Product
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0649-2016·2016-01-20
Beckman Coulter Recalls iChem 10 SG Urine Chemistry Strips
Beckman Coulter is recalling iChem 10 SG Urine Chemistry Strips because they may produce false positive leukocyte results for negative samples.
Product
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0634-2016·2016-01-20
Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error
Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.
Product
Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2016·2016-01-20
Boston Scientific Recalls Three Pacemakers Due to Incorrect Literature Packet
Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.
Product
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0620-2016·2016-01-20
Boston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling
Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.
Product
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0633-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error
Perkinelmer is recalling 60 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, leading to erroneous results.
Product
Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0635-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.
Product
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Category
Medical Device
Distribution
Distributed nationwide

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