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 39968

HighFDA (Devices)·Z-1729-2024·2024-05-08
Zimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect
Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.
Product
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2024·2024-05-08
POWERSEAL surgical sealer malfunction causes incomplete seal cycle
Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.
Product
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2024·2024-05-08
Abbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.
Product
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Category
Medical Device
Distribution
Distributed nationwide
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-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-1714-2024·2024-05-08
Zimmer Locking Plate System recalled due to thread mating defect
Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-16
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-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-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-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-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-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-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-1749-2024·2024-05-08
Radiation therapy planning system doses may be calculated incorrectly
Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.
Product
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2024·2024-05-08
Zimmer Periarticular Locking Plate System recalled due to faulty screw threads
Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.
Product
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-10
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-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-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-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-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-1716-2024·2024-05-08
Zimmer Locking Plate System Recalls Distal Fibular Plates Due to Thread Defect
Zimmer recalls distal fibular plates with defective locking holes that may prevent proper screw fixation during orthopedic surgery, potentially requiring additional intervention.
Product
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
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-1719-2024·2024-05-08
Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall
Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.
Product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
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-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

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7351–7375 of 39968