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

8051–8075 of 40007

HighFDA (Devices)·Z-1042-2024·2024-02-14
Prestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher
BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.
Product
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reduc
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0990-2024·2024-02-14
Flow-c Anesthesia System cybersecurity vulnerability in 14 units
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
Product
Flow-c Anesthesia System, model 6887700
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1004-2024·2024-02-14
Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging
Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.
Product
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1053-2024·2024-02-14
Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
Product
Bubble Sensor (REF: 70105.5720)
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0998-2024·2024-02-14
Sperm separation media kits recalled for incorrect component lot
Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.
Product
Sperm separation media are used to separate motile sperm from other constituents of semen.
Category
Medical Device
Distribution
22 states
CriticalFDA (Devices)·Z-0776-2024·2024-02-07
Medical Device Compressor Kits Recalled for Elevated Formaldehyde Levels
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
Product
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0863-2024·2024-02-07
Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects
Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.
Product
smiths medical Medfusion Model 3500 Syringe pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0864-2024·2024-02-07
Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.
Product
smiths medical Medfusion Model 4000 syringe pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0941-2024·2024-02-07
Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
Product
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0942-2024·2024-02-07
EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk
Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.
Product
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0933-2024·2024-02-07
EZDilate esophageal balloons recalled for inflation failure and device leaking
Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.
Product
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0774-2024·2024-02-07
EVair Air Compressors Recalled for Elevated Formaldehyde Emissions
EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.
Product
EVair air compressor, model numbers: M1230849 and M1230847
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0939-2024·2024-02-07
EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues
Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.
Product
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0940-2024·2024-02-07
Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Product
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0775-2024·2024-02-07
FDA recalls EVair 03 compressor models for elevated formaldehyde levels
FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).
Product
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0944-2024·2024-02-07
Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
Product
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Oxidation and Degradation
Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting material properties.
Product
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2024·2024-02-07
Knee Replacement Implant Component Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2024·2024-02-07
Cardiac surgical kits recalled due to improper sterilization exposure
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
Product
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2024·2024-02-07
Cortera Spinal Fixation System screws recalled for incorrect dimensions
XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0876-2024·2024-02-07
Knee Implant Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2024·2024-02-07
MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk
Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.
Product
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0874-2024·2024-02-07
Knee replacement tibial insert recalled for potential material oxidation
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2024·2024-02-07
Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
Product
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Category
Medical Device
Distribution
Distributed nationwide

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8051–8075 of 40007