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

9826–9850 of 13748

HighFDA (Devices)·Z-1149-2023·2023-03-01
Siemens Atellica IM Folate 140 test kit recalled for measurement bias
Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.
Product
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2023·2023-03-01
HydroMID Peripheral Access Kit Recalled for Mislabeled Packaging
Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.
Product
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1161-2023·2023-03-01
Sterile Oncology Port Access Tray Recalled for Sterilization Failure
Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.
Product
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1143-2023·2023-03-01
Hepatitis B Diagnostic Test Kits Recalled for Test Interference
Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.
Product
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1152-2023·2023-03-01
Diagnostic folate test kits recalled for negative measurement bias
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.
Product
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2023·2023-03-01
Atellica IM Folate test kit recalled for measurement bias issues
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
Product
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1150-2023·2023-03-01
Siemens Atellica IM Folate 700 test kit recalled for measurement bias
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Product
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1156-2023·2023-03-01
HydroMID 4Fr Peripheral Venous Catheter Kit Recalled for Incorrect Component Labeling
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.
Product
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1168-2023·2023-03-01
Diagnostic imaging system recalled due to ceiling and wall collision risk
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
Product
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1144-2023·2023-03-01
Hologic Mammography Systems Recalled for Unexpected C-Arm Movement
Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.
Product
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1159-2023·2023-03-01
IV Start Kit Recalled Due to Connector Manufacturing Defect
Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.
Product
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2023·2023-03-01
Folate test kits recalled for calibration error causing inaccurate results
Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.
Product
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2023·2023-03-01
Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.
Product
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1158-2023·2023-03-01
IV Access Device Kit Recalled Due to Manufacturing Defect in Connector
Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.
Product
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1163-2023·2023-03-01
Medline Sterile Hand Pack recalled for inadequate sterilization
Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.
Product
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2023·2023-03-01
Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk
Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.
Product
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1165-2023·2023-03-01
Diagnostic imaging system recalled for collision risk from default settings
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
Product
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1162-2023·2023-03-01
Medline Sterile Maximum Barrier Pack-LF units recalled for sterilization failure
Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.
Product
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Oran
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2023·2023-03-01
ADVIA Centaur Folate 500 test kits recalled for inaccurate measurement results
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.
Product
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2023·2023-03-01
IV START KIT Connector Defect May Cause Fluid Leaks
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
Product
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2023·2023-03-01
Luminos Agile Diagnostic Imaging System Collision Risk Recall
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
Product
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1160-2023·2023-03-01
Respiratory care breathing circuits recalled for incorrect expiration date labeling
S & MOHR AMERICA recalled approximately 1,320 abm Respiratory Care Standard Breathing Circuits due to incorrect expiration dates printed on product labels. The manufacturing date was printed where the expiration date should appear.
Product
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1126-2023·2023-02-22
Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility
Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.
Product
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2023·2023-02-22
Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise
Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.
Product
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2023·2023-02-22
Siemens Biograph Vision PET Scanner Gantry Locking Mechanism Recall
Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.
Product
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Category
Medical Device
Distribution
Distributed nationwide

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9826–9850 of 13748