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

9226–9250 of 40056

HighFDA (Devices)·Z-2551-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; 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-2550-2023·2023-09-20
Landauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.
Product
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; 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
ModerateFDA (Devices)·Z-2535-2023·2023-09-20
Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2543-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2576-2023·2023-09-20
Microbiologics KWIK-STIK ANA quality control set missing strain
Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.
Product
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2532-2023·2023-09-20
ASG-001 ultrasound gel recalled for mislabeling regarding use instructions
Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.
Product
ASG-001; Ultrasound gel
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2581-2023·2023-09-20
Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement
Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.
Product
Welch Allyn Connex Spot Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2536-2023·2023-09-20
Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2580-2023·2023-09-20
Denture relining kit recalled for outer box labeling error
Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.
Product
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2579-2023·2023-09-20
Copaliner Cavity Varnish Recalled for Solvent Mislabeling Error
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
Product
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2533-2023·2023-09-20
Ultrasound gel recalled for mislabeling with inappropriate use instructions
Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.
Product
50-GEL20; Ultrasound gel
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2569-2023·2023-09-20
Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.
Product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2562-2023·2023-09-20
Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Product
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
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-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
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-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-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-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-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-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-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-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

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9226–9250 of 40056