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

6776–6800 of 13512

HighFDA (Devices)·Z-1368-2024·2024-04-03
Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk
Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.
Product
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1358-2024·2024-04-03
Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2024·2024-04-03
MediBeads Neck Wrap recalled for potential mold and mildew growth
Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.
Product
MediBeads Neck Wrap, Item Number 34320
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2024·2024-04-03
SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord
Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.
Product
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1372-2024·2024-04-03
Laboratory performance verifier recalled for mismatched diluent assembly
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
Product
VITROS Performance Verifier I
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2024·2024-04-03
Philips Patient Information Center Custom Ringtones Fail When Screen Locked
Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.
Product
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1376-2024·2024-04-03
Access Substrate Reagent Bottles Recalled for Missing Product Labels
Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.
Product
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1363-2024·2024-04-03
Thermalon Neck Wrap recalled due to potential mold and mildew growth
Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.
Product
Thermalon Neck Wrap, Item Number 24322
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1387-2024·2024-04-03
CareEvent Event Management System notification failure on locked iOS devices
The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.
Product
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1364-2024·2024-04-03
Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth
Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.
Product
Thermalon Heating Pad, Item Number 24002
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1300-2024·2024-03-27
FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
Product
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular As
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1275-2024·2024-03-27
Smiths Medical Pneupac Plus 300 Ventilator Cycling Malfunction
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
Product
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1267-2024·2024-03-27
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
Product
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) R
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1301-2024·2024-03-27
HeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
Product
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LV
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1274-2024·2024-03-27
Smiths Medical Pneupac paraPAC plus 310 ventilators recalled for malfunction
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
Product
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2024·2024-03-27
Preat Nobel RP Titanium Abutment Blank Recalled for Manufacturing Defect
Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.
Product
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2024·2024-03-27
ECMO heat exchanger module recalled due to water path restriction
Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.
Product
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2024·2024-03-27
Directional Laser Probe Recalled for Fiber Extension and Direction Failure
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Product
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1304-2024·2024-03-27
Siemens DCA HbA1c Reagent Kit Recalled for Inaccurate Test Results
Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.
Product
DCA Systems HbA1c Reagent Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2024·2024-03-27
MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures
Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2024·2024-03-27
TMINI Knee Instrument Array Guide May Bind During Surgical Drilling
A precision component in Think Surgical's TMINI robotic knee system may bind due to insufficient clearance. The binding could occur during surgical drilling.
Product
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2024·2024-03-27
Guidewire Introducer Sheath Recalled for Internal Lumen Voids
Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.
Product
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2024·2024-03-27
Medical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.
Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1308-2024·2024-03-27
Curaplex Nasal Intubation Kit with incompatible tube holder recalled
Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.
Product
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2024·2024-03-27
Surgical Guidewire Introducer Sheath Recalled for Internal Manufacturing Defects
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Category
Medical Device
Distribution
Distributed nationwide

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6776–6800 of 13512