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

31251–31275 of 40449

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
ModerateFDA (Devices)·Z-0650-2016·2016-01-20
Biomet Hip Stem Recall for Incorrect PMMA Labeling
Biomet is recalling 21 hip stem implants because the label incorrectly lists PMMA as a material, though the product does not contain it.
Product
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0629-2016·2016-01-20
Stryker Tourniquet Cuffs Recalled for Mislabeling Port Configuration
Stryker is recalling 450 reprocessed tourniquet cuffs because they were mislabeled regarding their port configuration.
Product
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0632-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recall Due to 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 1-detector, 550 samples Product Code: 2470-0010 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-0628-2016·2016-01-20
BD Biosciences Recalls FMC7 FITC Reagent Due to Functional Degradation
Becton, Dickinson and Company is recalling FMC7 FITC reagents because functional degradation reduces the percent positive from 100% to approximately 87%.
Product
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 22 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, 1000 samples. Product Code: 2470-0200, 3470-0200. 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-0647-2016·2016-01-20
Brainlab Brain Metastases Software Recall for Image Display Errors
Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.
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
ModerateFDA (Devices)·Z-0654-2016·2016-01-20
Zimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
Zimmer Biomet is recalling 52 orthopedic plates because the package labels did not match the products inside.
Product
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0638-2016·2016-01-20
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling 188 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 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0588-2016·2016-01-13
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
Product
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0478-2016·2016-01-13
Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion
Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.
Product
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0592-2016·2016-01-13
Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.
Product
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET…
Category
Medical Device
Distribution
Distributed nationwide

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31251–31275 of 40449