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

7326–7350 of 40007

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-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-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-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-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-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-1698-2024·2024-05-08
Lumbar Interbody Fusion Curette Recalled for Potential Blade Shearing
Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.
Product
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2024·2024-05-08
Olympus POWERSEAL Surgical Sealer Recalled for Non-Functional Seal Activation
Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.
Product
POWERSEAL 5 mm, 44 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-0544CJDA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1723-2024·2024-05-08
ZPLP Distal Lateral Fibular Plates: locking screws may not secure
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.
Product
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
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-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-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-1699-2024·2024-05-08
Olympus POWERSEAL Sealer Recalled for Incomplete Seal Malfunction
Olympus Corporation is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider due to a device malfunction where the sealer fails to deliver energy upon activation, resulting in incomplete seal cycles and surgical delay.
Product
POWERSEAL 5 mm, 23 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-0523CJDA
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-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-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-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-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-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-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-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-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-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-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

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7326–7350 of 40007