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

5501–5525 of 27375

HighFDA (Devices)·Z-1707-2024·2024-05-08
Zirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide dental blocks nationwide due to defective units that may crack during sintering and cause dental restoration fracture.
Product
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2024·2024-05-08
RayStation radiation therapy system dosing parameter recall
RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.
Product
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1726-2024·2024-05-08
Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking
A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.
Product
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
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-1744-2024·2024-05-08
Radiation Therapy Planning System May Report Dose Values Too High
RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.
Product
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1695-2024·2024-05-08
Abbott Aveir Leadless Pacemaker May Experience Mode Changes Due to Electromagnetic Interference
Abbott Medical is recalling certain Abbott Aveir Leadless Pacemakers due to potential electromagnetic interference that could cause mode changes. The recall affects 10,610 units distributed nationwide.
Product
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2024·2024-05-08
Zimmer Periarticular Locking Plates Recalled for Potential Loss of Surgical Fixation
Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
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-1703-2024·2024-05-08
Zirconium Oxide Dental Blocks Recalled Due to Fracture Risk
IVOCLAR VIVADENT AG is recalling 2,286 units of zirconium oxide blocks used for dental restorations because defective units may develop cracks during processing, potentially causing restorations to fracture in patients' mouths.
Product
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
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-1721-2024·2024-05-08
Zimmer Periarticular Locking Plate May Fail to Secure Fracture Fixation
Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1694-2024·2024-05-08
Keller Funnel 2 breast implant insertion devices recalled for potential coating defect
Allergan recalls Keller Funnel 2 devices due to potential missing lubricating coating on breast implants, which may affect insertion. No injuries reported.
Product
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2024·2024-05-08
Radiation therapy planning system may calculate patient doses too high
RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.
Product
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
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-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-1732-2024·2024-05-08
Medtronic Invos Sensor Cable Recalled for Manufacturing Defects
Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.
Product
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Category
Medical Device
Distribution
25 states
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-1751-2024·2024-05-08
RayStation radiation therapy planning system may report inaccurate dosimetry values
RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.
Product
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2024·2024-05-08
Radiation therapy planning system dose calculation error
RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.
Product
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2024·2024-05-08
Zirconium oxide dental blocks recalled for cracking risk
IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.
Product
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1697-2024·2024-05-08
Sofsilk Braided Silk sutures recalled due to excess sterilization
One lot of Sofsilk Braided Silk sutures (Product Number S-2782K) was exposed to more sterilization cycles than approved, which may reduce tensile strength and increase risks of wound complications and infections during surgery.
Product
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
Category
Medical Device
Distribution
0 states
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-1734-2024·2024-05-08
Galaxy System Wired Controller Recalled for Unintended Scope Motion
Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.
Product
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2024·2024-05-08
Battery Mobile X-ray Units Recalled for Anti-Fall System Interference
SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.
Product
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (A
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

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5501–5525 of 27375