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

7376–7400 of 40007

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
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-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
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
HighFDA (Devices)·Z-1622-2024·2024-05-01
TRIDENTII HEMI hip implant recalled for acetabular shell manufacturing defect
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER48D hip implant because the acetabular shell may have excessive deburring, resulting in a smooth surface on the shell edge.
Product
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1619-2024·2024-05-01
Lead Wire Replacement Parts Recalled for Sheath Damage and Treatment Signal Loss
EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.
Product
48" Lead Wires, Replacement Part Number: 1067724-4
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-1637-2024·2024-05-01
Medical diagnostic test kits recalled due to misaligned results window
Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1631-2024·2024-05-01
Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
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-1688-2024·2024-05-01
PIEZON Bottle May Disassemble Under Pressure During Dental Use
FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.
Product
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1635-2024·2024-05-01
Palindrome Precision H Chronic Catheter Kit may lack labeled heparin coating
Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.
Product
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1617-2024·2024-05-01
Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage
The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.
Product
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2024·2024-05-01
Philips Patient Information Center iX UPS devices recalled for potential power failure
Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.
Product
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500R
Category
Medical Device
Distribution
Distributed nationwide
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-1615-2024·2024-05-01
LightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection
XENEX LightStrike Blackout Curtains are recalled due to inadequate protection against UV and ozone exposure. Bystanders in rooms during device operation may experience temporary skin reddening, eye irritation, nausea, and headache.
Product
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2024·2024-05-01
Abbott Alinity m System camera generates error with certain tubes
Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.
Product
Alinity m System, Part Number: 08N53-002
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-1607-2024·2024-05-01
Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage
Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.
Product
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2024·2024-05-01
Hip Implant Acetabular Shell Recalled for Manufacturing Defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.
Product
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2024·2024-05-01
ACUSON Redwood 1.0 ultrasound displays incorrect cardiac measurement values
The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.
Product
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1618-2024·2024-05-01
Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure
EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.
Product
20" Lead Wires, Replacement Part Number: 1067724-2
Category
Medical Device
Distribution
Distributed nationwide

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7376–7400 of 40007