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

6626–6650 of 13652

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-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-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-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-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-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-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
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-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
SevereFDA (Devices)·Z-1464-2024·2024-05-01
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.
Product
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
Category
Medical Device
Distribution
0 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-1614-2024·2024-05-01
Route 92 Medical Reperfusion System Recalled for Potential Device Separation
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
Product
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1608-2024·2024-05-01
NexGen CR-Flex Femoral Components Recalled for Bonding Defect
Zimmer is recalling 5,546 units of NexGen CR-Flex Femoral Components due to a manufacturing defect where the fiber metal pad fails to bond properly to the substrate. Patients with these implants should contact their healthcare provider.
Product
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2024·2024-05-01
Hip implant recalled for acetabular shell deburring defect
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.
Product
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1632-2024·2024-05-01
Hip replacement acetabular shells recalled for deburring defect
Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2024·2024-05-01
Water bottles used in dental treatment devices recalled for disassembly risk
Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure during treatment or storage. No injuries have been reported.
Product
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1605-2024·2024-05-01
Mariner RDX Pedicle Screw Heads Recalled for Intraoperative Cross-Threading Risk
SeaSpine Orthopedics is recalling Mariner RDX pedicle screw heads because the thin lead-in thread poses a risk of cross-threading within the locking cap/screw head interface during surgery.
Product
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0590-2024·2024-05-01
Tissue Processor Recall: HistoCore PEGASUS May Produce Damaged Specimens
Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1626-2024·2024-05-01
Hip implant acetabular shell deburring defect triggers manufacturer recall
The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.
Product
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1625-2024·2024-05-01
TRIDENTII HEMI Hip Implant Acetabular Shell Deburring Defect Recall
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.
Product
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1599-2024·2024-05-01
ACUSON Juniper ultrasound systems display incorrect cardiac measurements
Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.
Product
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2024·2024-05-01
Redux Electrolyte Creme Recalled for Low Viscosity Defect
Parker Laboratories is recalling Redux Electrolyte Creme, a highly conductive medical electrolyte product, due to demonstrated low viscosity.
Product
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Category
Medical Device
Distribution
Distributed nationwide

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6626–6650 of 13652