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

13901–13925 of 31490

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-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-1620-2024·2024-05-01
Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery
SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.
Product
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1630-2024·2024-05-01
Hip prosthesis shells recalled for manufacturing deburring defect
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER52E hip prostheses with excessive deburring on the acetabular shell edge, which could affect implant stability. Three units were distributed nationwide and internationally.
Product
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
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 (Drugs)·D-0474-2024·2024-05-01
Minocycline Extended-Release Tablets Recalled for Manufacturing Quality Control Failure
EPI Health is recalling minolira extended-release tablets due to manufacturer discontinuation of quality control programs affecting product identity, strength, and purity. The recall covers 12,808 bottles distributed nationwide.
Product
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1606-2024·2024-05-01
Alcon Custom Paks Surgical Procedure Packs recalled for cannula defects
Alcon is recalling Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips in sterile cannulas used in ophthalmic surgery.
Product
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0473-2024·2024-05-01
Cloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation
EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.
Product
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2024·2024-05-01
Quidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Category
Medical Device
Distribution
44 states
HighFDA (Drugs)·D-0475-2024·2024-05-01
Minolira extended-release tablets recalled due to discontinued quality assurance program
EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.
Product
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0471-2024·2024-05-01
Prescription respiratory drug recalled for short fill in unit-dose vials
Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.
Product
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2024·2024-05-01
Diagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export
ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.
Product
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1629-2024·2024-05-01
Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.
Product
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2024·2024-05-01
Hip Implant Acetabular Shell May Have Excessive Deburring Manufacturing Defect
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants because the acetabular shell may have excessive deburring, creating a smooth surface on the edge of the shell.
Product
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
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-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-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-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-1686-2024·2024-05-01
Cleaner Bottles May Disassemble Under Pressure During Treatment
EMS CLEANER BOTTLES (Model EG-1000) for dental prophylaxis systems may disassemble under pressure during treatment or storage. FDA Class II recall; no injuries reported.
Product
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device du
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-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-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 (Drugs)·D-0464-2024·2024-05-01
FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect
The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.
Product
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Category
Drug
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 (Food)·F-1177-2024·2024-05-01
Amy's Kitchen Enchilada Verde Whole Meal Recalled for Listeria Contamination
Amy's Kitchen Enchilada Verde frozen meals are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed to 21 U.S. states.
Product
Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
Category
Food
Distribution
21 states

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13901–13925 of 31490