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

6476–6500 of 13543

HighFDA (Devices)·Z-1727-2024·2024-05-08
Zimmer Fibular Plate Recall: Defective Locking Hole Threading
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.
Product
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2024·2024-05-08
Zimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.
Product
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1705-2024·2024-05-08
Zirconium oxide dental blocks recalled due to cracking and fracture risk
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental restorations to fracture in patients' mouths.
Product
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2024·2024-05-08
Zirconium oxide dental blocks recalled due to cracking risk
IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.
Product
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2024·2024-05-08
RayStation Radiation Therapy Planning Software Recalled for Calculation Error
RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.
Product
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2024·2024-05-08
Zimmer Distal Lateral Fibular Plate may fail to lock screws securely
Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2024·2024-05-08
Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
Product
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1739-2024·2024-05-08
Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments
Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.
Product
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2024·2024-05-08
Radiation therapy planning system may report overly high skin surface doses
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
Product
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2024·2024-05-08
Hip Cup Removal Instrument Recalled Due to Wrong Blade Assembly
Innomed is recalling the Cup Removal Starter Instrument due to a manufacturing error where the finisher blade was affixed instead of the starter blade. The wrong blade could compromise surgical performance during hip replacement procedures.
Product
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1696-2024·2024-05-08
OsmoPRO MAX Clinical Osmometer Recall for Software Errors and Result Inaccuracy
Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.
Product
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2024·2024-05-08
Philips Spectral CT Oncology Imaging System Recall: Laser Reflection Hazard
Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.
Product
The Oncology Essentials Package of the Spectral CT imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2024·2024-05-08
RayStation radiation therapy planning software affected by source-to-surface distance calculation error
RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.
Product
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2024·2024-05-08
Zimmer Distal Lateral Fibular Plate may fail to lock properly
Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2024·2024-05-08
RayStation Radiation Therapy System Recalled for Potential Dosing Error
RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.
Product
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1706-2024·2024-05-08
Zirconium oxide dental restoration blocks may develop cracks during sintering
IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.
Product
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2024·2024-05-08
Unsterilized Jackson-Pratt surgical drain kits recalled by Cardinal Health
Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.
Product
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2024·2024-05-08
Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect
Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.
Product
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2024·2024-05-08
Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination
Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.
Product
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2024·2024-05-08
Zimmer Fibular Plate Recall: Locking Hole Thread Form Defect
Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1741-2024·2024-05-08
RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.
Product
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1612-2024·2024-05-01
Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk
Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.
Product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1613-2024·2024-05-01
Route 92 Medical delivery catheter recalled due to tip separation risk
Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.
Product
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1610-2024·2024-05-01
Route 92 Medical Access System Recalled for Distal Tip Separation
Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.
Product
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Devices)·Z-1611-2024·2024-05-01
Route 92 Medical Reperfusion System Potential Catheter Tip Separation
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
Product
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states

How to read this listing

Filters

6476–6500 of 13543