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

12551–12575 of 13816

ModerateFDA (Devices)·Z-0334-2022·2021-12-15
Orthodontic Software Documentation Recalled for Unapproved Labeling Changes
Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.
Product
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0327-2022·2021-12-08
FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk
Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.
Product
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2022·2021-12-08
Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
Product
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2022·2021-12-08
Siemens Dimension Vista 500 software issue affects test accuracy
Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.
Product
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0315-2022·2021-12-08
INBONE Total Ankle System recalled for package-labeling mismatch
Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.
Product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0321-2022·2021-12-08
Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.
Product
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2022·2021-12-08
Blood collection devices recalled due to premature needle retraction
Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.
Product
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0328-2022·2021-12-08
Cholesterol test system recalled due to calibration failure
RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2022·2021-12-08
Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
Product
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2022·2021-12-08
Blood Culture Identification Test Recalled Due to False Positive Risk
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.
Product
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic me
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0323-2022·2021-12-08
Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled
Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.
Product
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2022·2021-12-08
UV-C Germicidal Wand Recalled for Excessive Ultraviolet-C Radiation
MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.
Product
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2022·2021-12-08
NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels
Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.
Product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0324-2022·2021-12-08
Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.
Product
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0317-2022·2021-12-08
HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity
O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.
Product
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2022·2021-12-08
Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
Product
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2022·2021-12-08
GE Centricity Medical Imaging Software May Display Incomplete Patient Studies
GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.
Product
GE Centricity Universal Viewer Zero Footprint Client
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0314-2022·2021-12-08
Orthopedic Implant Head Package Lid May Debond From Sealed Package
Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0308-2022·2021-12-08
Abbott HeartMate Touch System App may fail due to Bluetooth interference issue
The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.
Product
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2022·2021-12-08
Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss
Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.
Product
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2022·2021-12-08
Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults
Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.
Product
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0313-2022·2021-12-08
Orthopedic implant hip component recalled in Puerto Rico
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0319-2022·2021-12-08
NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection
NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.
Product
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-0310-2022·2021-12-08
Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls
DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0311-2022·2021-12-08
Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label
Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.
Product
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable
Category
Medical Device
Distribution
4 states

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12551–12575 of 13816