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

28201–28225 of 40357

ModerateFDA (Devices)·Z-0698-2017·2016-12-14
Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity
Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.
Product
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0704-2017·2016-12-14
Ultradent Recalls UltraSeal XT Plus Clear Refill Due to Labeling Error
Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Lot BD79T, because the package was mislabeled with an incorrect part number.
Product
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0692-2017·2016-12-14
Siemens Recalls SOMATOM Force CT Systems for Software Bugs
Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.
Product
SOMATOM Force, System x-ray, tomography, computed
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0726-2017·2016-12-14
Merge PACS software recall for horizontal image cut lines
Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.
Product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0718-2017·2016-12-14
Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.
Product
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0725-2017·2016-12-14
Randox Magnesium IVD Reagent Recalled for Carryover Interference
Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.
Product
Magnesium on RX Imola analyser IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0700-2017·2016-12-14
Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation
Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.
Product
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0713-2017·2016-12-14
DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints
DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.
Product
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0719-2017·2016-12-14
Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
Ivoclar Vivadent is recalling Virtual XD Test Pack dental impression material because it may fail to set properly as it ages.
Product
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0711-2017·2016-12-14
Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants
Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.
Product
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0695-2017·2016-12-14
Philips Ingenuity Core CT Systems Recalled for Software Error
Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.
Product
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient…
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-0694-2017·2016-12-14
Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.
Product
Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and…
Category
Medical Device
Distribution
46 states
LowFDA (Devices)·Z-0722-2017·2016-12-14
OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error
OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.
Product
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0367-2017·2016-12-07
Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.
Product
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468…
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0660-2017·2016-12-07
Elekta Monaco RTP System Recalled for Incorrect Dose Calculation
Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.
Product
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0684-2017·2016-12-07
MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk
MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.
Product
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2017·2016-12-07
Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results
Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.
Product
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0666-2017·2016-12-07
Hamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk
Hamilton Medical is recalling 44 MR1 ventilators because the oxygen tubing and connector could become loose during preparation, potentially compromising ventilation support.
Product
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays
Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0665-2017·2016-12-07
Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes
Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2017·2016-12-07
Domain Surgical Recalls FMsealer Open Shears Due to Jaw Fractures
Domain Surgical is recalling FMsealer Open Shears (Model FM3001) because fixed jaw fractures were observed during clinical usage.
Product
FMsealer Open Shears. Model FM3001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0688-2017·2016-12-07
MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction
MicroPort Orthopedics is recalling Conserve Cups because revision rate trends indicate a specific hazard of tissue reaction to metal debris.
Product
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2017·2016-12-07
MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk
MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.
Product
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns
Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2017·2016-12-07
Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns
Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.
Product
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow…
Category
Medical Device
Distribution
Distributed nationwide

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28201–28225 of 40357