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

7126–7150 of 27393

HighFDA (Devices)·Z-2568-2023·2023-09-20
Radiation monitoring dosimeter accuracy issue prompts FDA Class II recall
Landauer is recalling 427 nanoDot radiation monitoring dosimeters that may provide inaccurate radiation exposure readings. Some units may fall outside the specified ±5.5% accuracy range due to a manufacturing issue.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2572-2023·2023-09-20
Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy
Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.
Product
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2531-2023·2023-09-20
Remel Todd Hewitt Broth Culture Medium May Fail to Detect Target Organism
One lot of Remel Todd Hewitt Broth culture medium may fail to recover Group B Streptococci during testing or use with patient samples, potentially resulting in missed diagnoses.
Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2023·2023-09-20
Radiation dosimeter may report inaccurate exposure readings
Landauer recalls nanoDot D2DNN radiation dosimeters worldwide due to potential accuracy degradation that may cause incorrect exposure readings.
Product
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2524-2023·2023-09-20
Medtronic Bone Graft Recalled Due to Incorrect Size Labeling
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
Product
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2554-2023·2023-09-20
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2544-2023·2023-09-20
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Product
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2548-2023·2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2516-2023·2023-09-13
Fargo Ortho-K Contact Lens Recall Due to Missing FDA Approval
PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.
Product
Fargo Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2403-2023·2023-09-13
Azurion imaging systems recalled for stuck foot switch causing unintended radiation
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.
Product
Azurion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2023·2023-09-13
Medical Imaging System Recalled for Foot Pedal Malfunction Risk
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Product
MultiDiagnost-Eleva
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2402-2023·2023-09-13
Philips Allura Xper X-ray Systems Foot Pedal May Stick, Causing Unintended Radiation
Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.
Product
Allura Xper series
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2517-2023·2023-09-13
Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect
Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.
Product
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2519-2023·2023-09-13
Hip Prosthesis Implants Recalled for Size Mismatch Between Label and Device
Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.
Product
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2023·2023-09-13
Reusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.
Product
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2515-2023·2023-09-13
ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval
Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.
Product
ISee Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2518-2023·2023-09-13
Trocar with oversized shaft obscures surgical view in brain operations
Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.
Product
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2023·2023-09-13
Olympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels
Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.
Product
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2023·2023-09-13
Cook Lead Clipper Cardiac Device Sterility Recall Due to Packaging Defect
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
Product
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2432-2023·2023-09-06
Cardiosave Rescue Intra-Aortic Balloon Pumps Fail to Charge When Improperly Inserted
Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2467-2023·2023-09-06
EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2438-2023·2023-09-06
Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2436-2023·2023-09-06
Cardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2434-2023·2023-09-06
Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2431-2023·2023-09-06
Cardiosave Hybrid Intra-Aortic Balloon Pump charging issue recall
The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide

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7126–7150 of 27393