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

7351–7375 of 40007

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-1717-2024·2024-05-08
Zimmer Periarticular Locking Plate recalled for improper screw mating defect
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays or loss of fixation.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-08
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-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-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-1711-2024·2024-05-08
Zimmer Periarticular Locking Plate threading defect may compromise surgical fixation
Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2024·2024-05-08
Jackson-Pratt 3-Spring Reservoir Kit Recalled Due to Non-Sterile Shipment
Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.
Product
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2024·2024-05-08
Jackson-Pratt Drainage Kits Shipped Unsterilized in Voluntary Removal
Cardinal Health is voluntarily removing Jackson-Pratt drainage kits (Lot 210751D6) that were shipped without sterilization. The unsterilized devices pose an infection risk if used in patient care.
Product
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2024·2024-05-08
Zimmer surgical fracture plates may fail to lock properly
Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-04
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-1731-2024·2024-05-08
Medtronic Invos Infant Sensor Cables recalled for manufacturing defects
Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.
Product
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Category
Medical Device
Distribution
25 states
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-1724-2024·2024-05-08
Zimmer ZPLP Fibular Plate May Fail to Lock Properly During Surgery
The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.
Product
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
Category
Medical Device
Distribution
Distributed nationwide
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-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-1735-2024·2024-05-08
Jackson-Pratt 3-Spring Reservoir Drain Kits Shipped Without Sterilization
Cardinal Health is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits because they were shipped to users before sterilization. Unsterilized surgical drains pose an infection risk.
Product
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
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-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-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-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-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-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-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-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
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

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7351–7375 of 40007